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
f32dd451-3f7a-815b-e053-2995a90a528f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC.
DUNS: 036986393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Warfarin Sodium
PRODUCT DETAILS
NDC Product Code51655-629
Application NumberANDA040616
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 3, 2023
Generic NameWarfarin Sodium
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
WARFARIN SODIUMActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT