Warfarin Sodium (Page 8 of 8)

15. REFERENCES

OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16. HOW SUPPLIED/STORAGE AND HANDLING

Warfarin sodium tablets, USP are supplied as follows:

1 mg Tablets: Light pink, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘1’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-327-01) and 1000’s count (NDC 76282-327-10)

2 mg Tablets: Lavender, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-328-01) and 1000’s count (NDC 76282-328-10)

2.5 mg Tablets: Green, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘21 /2 on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-329-01) and 1000’s count (NDC 76282-329-10)

3 mg Tablets: Tan, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘3’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-330-01) and 1000’s count (NDC 76282-330-10)

4 mg Tablets: Blue, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘4’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-331-01) and 1000’s count (NDC 76282-331-10)

5 mg Tablets: Peach, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘5’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-332-01) and 1000’s count (NDC 76282-332-10)

6 mg Tablets: Teal, Round, Flat Beveled edge tablets de-bossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘6’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-333-01) and 1000’s count (NDC 76282-333-10)

7.5 mg Tablets: Yellow, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘71 /2 on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-334-01)

10 mg Tablets: White, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘10’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-335-01)

Storage: Store at 20° to 25°C (68° F to 77° F). [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

Special Handling
Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15)].

Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1)].

17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions for Patients

Advise patients to:

  • Strictly adhere to the prescribed dosage schedule [see Dosage and Administration (2.1)].
  • If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration (2.6)].
  • Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage and Administration (2.1)].
  • Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days [see Clinical Pharmacology (12.2)].
  • Avoid any activity or sport that may result in traumatic injury [see Use in Specific Populations (8.4)]. And to tell their physician if they fall often as this may increase their risk for complications.
  • Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables [see Drug Interactions (7.5)].
  • Contact their physician to report any serious illness, such as severe diarrhea, infection, or fever [see Warnings and Precautions (5) and Adverse Reactions (6)].
  • Immediately contact their physician when experiencing pain and discoloration of the skin (a purple bruise like rash) mostly on areas of the body with a high fat content, such as breasts, thighs, buttocks, hips and abdomen [see Warnings and Precautions (5.2)].
  • Immediately contact their physician when experiencing any unusual symptom or pain since Warfarin sodium may cause small cholesterol or athero emboli. On feet it may appear as a sudden cool, painful, purple discoloration of toe(s) or forefoot [see Warnings and Precautions (5.5)].
  • Immediately contact their physician when taking Warfarin sodium after any heparin formulation therapy and experiencing bloody or black stools or appearance of bruises, or bleeding [see Warnings and Precautions (5.6)].
  • To tell all of their healthcare professionals and dentists that they are taking Warfarin sodium. This should be done before they have any surgery or dental procedure [see Dosage and Administration (2.7)].
  • Carry identification stating that they are taking warfarin sodium.

Bleeding Risks

Advise patients to:

  • Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Box Warning and Warnings and Precautions (5.1)].

Concomitant Medications and Botanicals (Herbals)

Advise patients to:

  • Not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs, and botanical (herbal) products except on advice of your physician [see Drug Interactions (7)].

Pregnancy and Nursing

Advise patients to:

  • Notify their physician if they are pregnant or planning to become pregnant or considering breast feeding [see Use in Specific Populations (8.1, 8.2, 8.3)].
  • Avoid warfarin sodium during pregnancy except in pregnant women with mechanical heart valves, who are at risk of thromboembolism [see Contraindications (4)]. Use effective measures to avoid pregnancy while taking warfarin sodium. This is very important because their unborn baby could be seriously harmed if they take warfarin sodium while they are pregnant [see Use in Specific Populations (8.1, 8.3)].

Revised: 10/2019

MEDICATION GUIDE

Warfarin Sodium Tablets, USP
(war’ far in soe’ dee um)

What is the most important information I should know about warfarin sodium?

Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium is a blood thinner medicine that lowers the chance of blood clots forming in your body.

  • You may have a higher risk of bleeding if you take warfarin sodium and:
    • are 65 years of age or older
    • have a history of stomach or intestinal bleeding
    • have high blood pressure (hypertension)
    • have a history of stroke, or “mini-stroke” (transient ischemic attack or TIA)
    • have serious heart disease
    • have a low blood count or cancer
    • have had trauma, such as an accident or surgery
    • have kidney problems
    • take other medicines that increase your risk of bleeding, including:
      • a medicine that contains heparin
      • other medicines to prevent or treat blood clots
      • nonsteroidal anti-inflammatory drugs (NSAIDs)
    • take warfarin sodium for a long time. Warfarin sodium, is the active ingredient in warfarin sodium tablets.

Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.

Many other medicines can interact with warfarin sodium and affect the dose you need or increase warfarin sodium side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.

Do not take other medicines that contain warfarin sodium while taking warfarin sodium tablets.

  • Get your regular blood test to check for your response to warfarin sodium. This blood test is called an INR test. The INR test checks to see how fast your blood clots. Your healthcare provider will decide what INR numbers are best for you. Your dose of warfarin sodium will be adjusted to keep your INR in a target range for you.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
  • pain, swelling, or discomfort
  • headaches, dizziness, or weakness
  • unusual bruising (bruises that develop without known cause or grow in size)
  • nosebleeds
  • bleeding gums
  • bleeding from cuts takes a long time to stop
  • menstrual bleeding or vaginal bleeding that is heavier than normal
  • pink or brown urine
  • red or black stools
  • coughing up blood
  • vomiting blood or material that looks like coffee grounds
  • Some foods and beverages can interact with warfarin sodium and affect your treatment and dose.
  • Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of warfarin sodium.
  • Always tell all of your healthcare providers that you take warfarin sodium.
  • Wear or carry information that you take warfarin sodium.

See “What are the possible side effects of warfarin sodium?” for more information about side effects.

What is warfarin sodium?

Warfarin sodium is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.

Who should not take warfarin sodium?

Do not take warfarin sodium if:

  • your risk of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if warfarin sodium is right for you.
  • you are pregnant unless you have a mechanical heart valve. Warfarin sodium may cause birth defects, miscarriage, or death of your unborn baby.
  • you are allergic to warfarin or any of the other ingredients in warfarin sodium tablets. See the end of this leaflet for a complete list of ingredients in warfarin sodium tablets.

Before taking Warfarin sodium, tell your healthcare provider about all of your medical conditions, including if you:

  • have bleeding problems
  • fall often
  • have liver problems
  • have kidney problems or are undergoing dialysis
  • have high blood pressure
  • have a heart problem called congestive heart failure
  • have diabetes
  • plan to have any surgery or a dental procedure
  • are pregnant or plan to become pregnant. See “Who should not take warfarin sodium?
  • Your health care provider will do a pregnancy test before you start treatment with warfarin sodium. Females who can become pregnant should use effective birth control during treatment, and for at least 1 month after the last dose of warfarin sodium.
  • are breastfeeding. You and your health care provider should decide if you will take warfarin sodium and breastfeed. Check your baby for bruising or bleeding if you take warfarin sodium and breastfeed.

Tell all of your healthcare providers and dentists that you are taking warfarin sodium. They should talk to the healthcare provider who prescribed warfarin sodium for you before you have any surgery or dental procedure. Your warfarin sodium may need to be stopped for a short time or you may need your dose adjusted.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way warfarin sodium works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about warfarin sodium?

How should I take warfarin sodium?

  • Take warfarin sodium exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to warfarin sodium.
  • You must have regular blood tests and visits with your healthcare provider to monitor your condition.
  • If you miss a dose of warfarin sodium, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of warfarin sodium the next day to make up for a missed dose.
  • Call your healthcare provider right away if you:
  • take too much warfarin sodium
  • are sick with diarrhea, an infection, or have a fever
  • fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you

What should I avoid while taking warfarin sodium?

  • Do not do any activity or sport that may cause a serious injury.

    What are the possible side effects of warfarin sodium?

    Warfarin sodium may cause serious side effects, including:

  • See “What is the most important information I should know about warfarin sodium?
  • Death of skin tissue (skin necrosis or gangrene). This can happen soon after starting warfarin sodium. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
  • Kidney problems. Kidney injury may happen in people who take Warfarin sodium. Tell your healthcare provider right away if you develop blood in your urine. Your healthcare provider may do tests more often during treatment with Warfarin sodium to check for bleeding if you already have kidney problems.
  • “Purple toes syndrome.” Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

These are not all of the side effects of warfarin sodium. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store warfarin sodium?

  • Store warfarin sodium tablets at 20°C to 25°C (68°F to 77°F).
  • Keep warfarin sodium tablets in a tightly closed container.
  • Keep warfarin sodium tablets out of the light and moisture.
  • Follow your healthcare provider or pharmacist instructions about the right way to throw away outdated or unused warfarin sodium tablets.
  • Females who are pregnant should not handle crushed or broken warfarin sodium tablets.

Keep warfarin sodium tablets and all medicines out of the reach of children.

General information about the safe and effective use of warfarin sodium.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use warfarin sodium for a condition for which it was not prescribed. Do not give warfarin sodium to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about warfarin sodium. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about warfarin sodium that is written for health professionals.

If you would like more information, talk to your healthcare provider or call Exelan Pharmaceuticals, Inc. at 1-866-604-3268.

What are the ingredients in warfarin sodium tablets, USP?

Active ingredient: Warfarin Sodium, USP

Inactive ingredients: Lactose monohydrate, starch, pregelatinized starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each:

1 mg tablet contains: D&C Red #30 aluminum lake

2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2

2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#2

3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake

4 mg tablet contains: FD&C Blue#2

5 mg tablet contains: FD&C Yellow # 6 aluminum lake

6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2

7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake

10 mg tablet is dye free.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Exelan Pharmaceuticals, Inc.

Lawrenceville, GA 30046

Manufactured By:

InvaGen Pharmaceuticals, Inc.

(a sunsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Revised: 10/2019

Rx only

PRINCIPAL DISPLAY PANEL

NDC 76282-327-01

Warfarin Sodium Tablets, USP

Crystalline* 1 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

1mg-100
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-328-01

Warfarin Sodium Tablets, USP

Crystalline* 2 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM3
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-329-01

Warfarin Sodium Tablets, USP

Crystalline* 2.5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM4
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-330-01

Warfarin Sodium Tablets, USP

Crystalline* 3 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM5
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-331-01

Warfarin Sodium Tablets, USP

Crystalline* 4 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM7
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-332-01

Warfarin Sodium Tablets, USP

Crystalline* 5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM8
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-333-01

Warfarin Sodium Tablets, USP

Crystalline* 6 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM9
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-334-01

Warfarin Sodium Tablets, USP

Crystalline* 7.5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM10
(click image for full-size original)
PRINCIPAL DISPLAY PANEL

NDC 76282-335-01

Warfarin Sodium Tablets, USP

Crystalline* 10 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx Only 100 Tablets

EXELAN PHARMACEUTICALS, INC.

MM11
(click image for full-size original)
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-327
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
D&C RED NO. 30
Product Characteristics
Color PINK (Light pink) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-327-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-327-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-328
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE (Lavender) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-328-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-328-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-329
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;2;1;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-329-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-329-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-330
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color BROWN (Tan) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-330-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-330-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-331
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-331-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-331-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-332
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Peach) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-332-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-332-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-333
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 6 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
Product Characteristics
Color TURQUOISE (Teal) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-333-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-333-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-334
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;7;1;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-334-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-335
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code IG;W;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-335-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090935 04/08/2015
Labeler — Exelan Pharmaceuticals Inc. (967795266)
Registrant — InvaGen Pharmaceuticals, Inc (165104469)
Establishment
Name Address ID/FEI Operations
Invagen Pharmaceuticals Inc. 165104469 ANALYSIS (76282-327), ANALYSIS (76282-328), ANALYSIS (76282-329), ANALYSIS (76282-330), ANALYSIS (76282-331), ANALYSIS (76282-332), ANALYSIS (76282-333), ANALYSIS (76282-334), ANALYSIS (76282-335), MANUFACTURE (76282-327), MANUFACTURE (76282-328), MANUFACTURE (76282-329), MANUFACTURE (76282-330), MANUFACTURE (76282-331), MANUFACTURE (76282-332), MANUFACTURE (76282-333), MANUFACTURE (76282-334), MANUFACTURE (76282-335)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals, Inc 080334903 analysis (76282-327), analysis (76282-328), analysis (76282-329), analysis (76282-330), analysis (76282-331), analysis (76282-332), analysis (76282-333), analysis (76282-334), analysis (76282-335), pack (76282-327), pack (76282-328), pack (76282-329), pack (76282-330), pack (76282-331), pack (76282-332), pack (76282-333), pack (76282-334), pack (76282-335)

Revised: 10/2019 Exelan Pharmaceuticals Inc.

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