Manufacturing Establishments (1)

Taro Pharmaceutical Industries Ltd.

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

600072078

Products (9)

Warfarin Sodium

NDC Product Code

51672-4034

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 7.5 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4030

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 3 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4033

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 6 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4028

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 2 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4031

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 4 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

Warfarin Sodium

NDC Product Code

51672-4035

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 10 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4027

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C RED NO. 6 BARIUM LAKEInactive

Code: K4XZD9W99KClass: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 1 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4032

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C RED NO. 6 BARIUM LAKEInactive

Code: K4XZD9W99KClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 5 mg in 1 1

Warfarin Sodium

NDC Product Code

51672-4029

Application Number

ANDA040301

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 21, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

WarfarinActive

Code: 6153CWM0CLClass: ACTIBQuantity: 2.5 mg in 1 1

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 51672-4035-1
** 100 Tablets**

Warfarin Sodium
** Tablets, USP**Crystalline

10 mg

Dispense with
** Medication Guide**

PROTECT FROM LIGHT.
HIGHLY POTENT ANTICOAGULANT.

**WARNING:**Serious bleeding results from overdosage.
Do not use or dispense before reading directions and
warnings in accompanying product information.

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

DESCRIPTION SECTION

11 DESCRIPTION

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 C 19H 15NaO 4, and its structural formula is represented by the following:

Chemical Structure

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.

Warfarin sodium tablets, USP for oral use also contain:

All strengths: Anhydrous lactose, corn starch, and magnesium stearate

1 mg:	D&C Red No. 6 Barium Lake
2 mg:	FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake
2.5 mg:	D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake
3 mg:	D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake
4 mg:	FD&C Blue No. 1 Aluminum Lake
5 mg:	D&C Red No. 6 Barium Lake, D&C Yellow No. 10 Aluminum Lake
6 mg:	D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake
7.5 mg:	D&C Yellow No. 10 Aluminum Lake
10 mg:	Dye Free

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Warfarin Sodium

Manufacturing Establishments (1)

Taro Pharmaceutical Industries Ltd.

Products (9)

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Warfarin Sodium

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

DESCRIPTION SECTION

11 DESCRIPTION