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. Initial U.S. Approval: 1954
Approved
Approval ID
4445c26e-ec5c-40f4-956b-93c12fc73c1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4402
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
WARFARIN SODIUMActive
Quantity: 4 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT