Simvastatin (Page 9 of 9)

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using simvastatin. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking simvastatin and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should not use simvastatin. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

March 2014 FDA-14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RANBAXY

NDC 63304-789-30

SIMVASTATIN

Tablets , USP

5 mg

30 Tablets

Rx only

30's bottle label
(click image for full-size original)

30’s bottle label

RANBAXY

NDC 63304-790-90

SIMVASTATIN

Tablets, USP

10 mg

90 Tablets

Rx only

90's bottle label
(click image for full-size original)

90’s bottle label

RANBAXY

NDC 63304-791-90

SIMVASTATIN

Tablets, USP

2 0 mg

90 Tablets

Rx only

90's bottle label
(click image for full-size original)

90’s bottle label

RANBAXY

NDC 63304-792-90

SIMVASTATIN

Tablets, USP

4 0 mg

9 0 Tablets

Rx only

90's bottle label
(click image for full-size original)

90’s bottle label

RANBAXY

NDC 63304-793-90

SIMVASTATIN

Tablets, USP

8 0 mg

90 Tablets

Rx only

90's bottle label
(click image for full-size original)

90’s bottle label

SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-789
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 5 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color orange (peach colored) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code RX6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-789-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-789-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-789-10 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076285 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-790
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color orange (peach colored) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX790
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-790-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-790-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-790-10 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076285 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-791
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (tan colored) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code RX791
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-791-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-791-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-791-10 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076285 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-792
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color red (brick red colored) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code RX792
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-792-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-792-50 50 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-792-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:63304-792-10 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076285 12/20/2006
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-793
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color red (brick red colored) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code RX793
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-793-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-793-50 50 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-793-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:63304-793-10 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076285 12/20/2006
Labeler — Ranbaxy Pharmaceuticals Inc. (937890044)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ranbaxy Laboratories Limited_Toansa 650441632 api manufacture (63304-789), api manufacture (63304-790), api manufacture (63304-791), api manufacture (63304-792), api manufacture (63304-793)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc._Terminal Rd 184769029 manufacture (63304-789), manufacture (63304-790), manufacture (63304-791), manufacture (63304-792), manufacture (63304-793), pack (63304-789), pack (63304-790), pack (63304-791), pack (63304-792), pack (63304-793)

Revised: 03/2014 Ranbaxy Pharmaceuticals Inc.

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