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, for oral use Initial U.S. Approval: 1954
Approved
Approval ID
4f276251-49b7-438f-9c47-f1cdfc47e519
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 8
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 Code43353-053
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WARFARIN SODIUMActive
Quantity: 7.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-023
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-054
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-030
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-033
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WARFARIN SODIUMActive
Quantity: 4 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-028
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 1 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-029
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WARFARIN SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-021
Application NumberANDA090935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2015
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 2 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 BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT