COUMADIN Tablet Ref.[10550] Active ingredients: Warfarin

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

COUMADIN (warfarin sodium) tablets 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 empirical formula is C₁₉H₁₅NaO₄, and its structural formula is represented by the following:

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.

COUMADIN tablets for oral use also contain:

All strengths:	Lactose, starch, and magnesium stearate
1 mg:	D&C Red No. 6 Barium Lake
2 mg:	FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake
2-1/2 mg:	D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake
3 mg:	FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake
4 mg:	FD&C Blue No. 1 Aluminum Lake
5 mg:	FD&C Yellow No. 6 Aluminum Lake
6 mg:	FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake
7-1/2 mg:	D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake
10 mg:	Dye-free

Dosage Forms and Strengths

Tablets:

COUMADIN Single-Scored Tablets
Strength	Color	Superimposed Imprint
1 mg	Pink	1
2 mg	Lavender	2
2.5 mg	Green	2-1/2
3 mg	Tan	3
4 mg	Blue	4
5 mg	Peach	5
6 mg	Teal	6
7.5 mg	Yellow	7-1/2
10 mg	White (dye-free)	10

How Supplied
Tablets COUMADIN tablets are single-scored with one face imprinted numerically with 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 superimposed and inscribed with “COUMADIN” and with the opposite face plain. COUMADIN is available in bottles and hospital unit-dose blister packages with potencies and colors as follows: 1 mg pink Overbagged with 10 tablets per bag NDC 55154-7701-0 2 mg lavender Overbagged with 10 tablets per bag NDC 55154-7702-0 2-1/2 mg green Overbagged with 10 tablets per bag NDC 55154-7703-0 3 mg tan Overbagged with 10 tablets per bag NDC 55154-7716-0 5 mg peach Overbagged with 10 tablets per bag NDC 55154-7704-0 7-1/2 mg yellow Overbagged with 10 tablets per bag NDC 55154-7706-0 Distributed by: Bristol-Myers Squibb Company, Princeton, New Jersey 08543, USA COUMADIN is a trademark of Bristol-Myers Squibb Pharma Company. Distributed by: Cardinal Health, Dublin, OH 43017

Drugs

Drug	Countries
COUMADIN	Australia, Germany, Israel, New Zealand, United Kingdom, United States

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