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
e7f78a33-71eb-4aac-ba9d-70f75136fab0
HUMAN PRESCRIPTION DRUG LABEL
Aug 20, 2025
Bryant Ranch Prepack
DUNS: 171714327
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
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Warfarin Sodium 5 mg Tab #100
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Dosage and Administration, Renal Impairment (2.5) 5/2017
Warnings and Precautions, Acute kidney injury (5.4) 5/2017
Dosage and Administration, Renal Impairment (2.5) 5/2017
Warnings and Precautions, Acute kidney injury (5.4) 5/2017
DESCRIPTION SECTION
11 DESCRIPTION
Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows:
C19H15NaO4 M.W. 330.31
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
The 1 mg also contains FD&C red no. 40.
The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake.
The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.
The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake.
The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake.
The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake.
The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.
The 7.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C yellow no. 6 aluminum lake.