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
4f2fd912-7869-4e49-b5ff-848b0f1277ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2014
Manufacturers
FDA
ReadyMeds
DUNS: 072115132
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64205-032
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2014
FDA Product Classification
INGREDIENTS (8)
Warfarin SodiumActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C Red No. 6Inactive
Code: 481744AI4O
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
Barium OxideInactive
Code: 77603K202B
Classification: IACT