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 useInitial U.S. Approval: 1954
Approved
Approval ID
73048ed9-242f-4f86-a8db-9c7547daa01d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2020
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-745
Application NumberANDA040616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (8)
WARFARIN SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-750
Application NumberANDA040616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT