Warfarin Sodium
These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP for oral use Initial U.S. Approval: 1954
Approved
Approval ID
6982c863-84bf-ddd6-e053-2a91aa0aacd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4385
Application NumberANDA090935
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 17, 2022
Generic NameWarfarin Sodium
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WARFARIN SODIUMActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT