Warfarin Sodium (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65162-761-10

Warfarin Sodium Tablets USP, 1 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

10
(click image for full-size original)


NDC 65162-762-10

Warfarin Sodium Tablets USP, 2 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

20
(click image for full-size original)

NDC 65162-763-10

Warfarin Sodium Tablets USP, 2.5 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

30
(click image for full-size original)

NDC 65162-764-10

Warfarin Sodium Tablets USP, 3 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

60
(click image for full-size original)

NDC 65162-765-10

Warfarin Sodium Tablets USP, 4 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

30
(click image for full-size original)

NDC 65162-766-10

Warfarin Sodium Tablets USP, 5 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

30
(click image for full-size original)

NDC 65162-767-10

Warfarin Sodium Tablets USP, 6 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

10
(click image for full-size original)

NDC 65162-768-10

Warfarin Sodium Tablets USP, 7.5 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

10
(click image for full-size original)

NDC 65162-769-10

Warfarin Sodium Tablets USP, 10 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

60
(click image for full-size original)

WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-761
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
D&C RED NO. 6
Product Characteristics
Color PINK (light) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 761;1;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-761-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-761-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-761-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-762
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE (Light Lavender) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 762;2;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-762-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-762-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-762-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-763
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN (light) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 763;2;1;2;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-763-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-763-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-763-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-764
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color BROWN (light tan) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 764;3;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-764-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-764-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-764-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-765
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (Light) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 765;4;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-765-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-765-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-765-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-766
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Light peach) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 766;5;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-766-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-766-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-766-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-767
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
Product Characteristics
Color TURQUOISE (light teal) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 767;6;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-767-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-767-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-767-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-768
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW (Light) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 768;7;1;2;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-768-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-768-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-768-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
WARFARIN SODIUM warfarin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-769
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
HYDROXYPROPYL CELLULOSE (70000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 769;10;AN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-769-10 100 TABLET in 1 BOTTLE None
2 NDC:65162-769-11 1000 TABLET in 1 BOTTLE None
3 NDC:65162-769-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202202 08/16/2010
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 915076126 ANALYSIS (65162-761), ANALYSIS (65162-761), ANALYSIS (65162-762), ANALYSIS (65162-763), ANALYSIS (65162-764), ANALYSIS (65162-765), ANALYSIS (65162-766), ANALYSIS (65162-767), ANALYSIS (65162-768), ANALYSIS (65162-769), LABEL (65162-761), LABEL (65162-761), LABEL (65162-762), LABEL (65162-763), LABEL (65162-764), LABEL (65162-765), LABEL (65162-766), LABEL (65162-767), LABEL (65162-768), LABEL (65162-769), MANUFACTURE (65162-761), MANUFACTURE (65162-761), MANUFACTURE (65162-762), MANUFACTURE (65162-763), MANUFACTURE (65162-764), MANUFACTURE (65162-765), MANUFACTURE (65162-766), MANUFACTURE (65162-767), MANUFACTURE (65162-768), MANUFACTURE (65162-769), PACK (65162-761), PACK (65162-761), PACK (65162-762), PACK (65162-763), PACK (65162-764), PACK (65162-765), PACK (65162-766), PACK (65162-767), PACK (65162-768), PACK (65162-769)

Revised: 12/2019 Amneal Pharmaceuticals LLC

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