Warfarin Sodium
These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
Approved
Approval ID
558b7a0d-5490-4c1b-802e-3ab3f1efe760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-762
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 2 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-769
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (5)
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-767
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 6 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-761
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
WARFARIN SODIUMActive
Quantity: 1 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 6Inactive
Code: 481744AI4O
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-763
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-766
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-765
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
WARFARIN SODIUMActive
Quantity: 4 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-768
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 7.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-764
Application NumberANDA202202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2022
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
WARFARIN SODIUMActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT