Warfarin Sodium

Product NDC: 51672-4031
Requested package NDC: 51672-4031-7
11-digit product format: 516724031
Labeler code: 51672
Product ID: 51672-4031_373f3fe2-c159-028e-e063-6394a90aff59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040301
Marketing category: ANDA
Marketing start: 1999-07-15
Substance: WARFARIN SODIUM
Active strength: 4 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040301-001	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15
A040301-002	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15
A040301-003	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15
A040301-004	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15
A040301-005	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15
A040301-006	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15
A040301-007	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15
A040301-008	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15
A040301-009	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
A040301-001	AB
A040301-002	AB
A040301-003	AB
A040301-004	AB
A040301-005	AB
A040301-006	AB
A040301-007	AB
A040301-008	AB
A040301-009	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040301-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040301-009	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	8cd0e744-b499-4344-b1db-59f85950e169	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	991b1e3e-236e-44cf-ad61-7233f777ce67	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	6b227c9e-02e9-4ec9-8b11-3ab6fe5093e5	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	72d3ea20-27e4-4368-a666-a9b76530dbb9	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	61ab23a7-bc67-4777-854a-bf43c788a69a	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	7b3b6f89-1feb-4939-a95b-7ad0707f4d76	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	73b8e5ab-86f8-44f8-b290-346acb81c9ae	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Cardinal Health 107, LLC	cdbbc317-35d3-42ba-94f0-c83891358529	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	694e258d-86bd-440c-870b-a7d27fb1c467	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Golden State Medical Supply, Inc.	ba8b4ead-d080-91e7-e053-2995a90a82fe	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Sun Pharmaceutical Industries, Inc.	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301 ndc (package): 51672-4031-7 ndc (product): 51672-4031 ndc11 (package): 51672403107
Warfarin Sodium	WARFARIN SODIUM	Cardinal Health 107, LLC	7c4deb97-9966-4c8e-9ba6-bb260b71e130	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	American Health Packaging	ab047628-67d0-4a64-8d77-36b054969b44	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	American Health Packaging	feaa5f6f-9753-4f37-ab81-04c9c6b45e6a	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e73d37f8-8a28-4d93-9529-fd1e2c84228a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2c8f47c6-a180-4ad8-b962-04069d2270cb	2021-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301

Additional Listing Data#

Finished product: Yes
Brand name base: Warfarin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WARFARIN SODIUM	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6153CWM0CL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855288	Internal RxNorm lookup
855296	Internal RxNorm lookup
855302	Internal RxNorm lookup
855312	Internal RxNorm lookup
855318	Internal RxNorm lookup
855324	Internal RxNorm lookup
855332	Internal RxNorm lookup
855338	Internal RxNorm lookup
855344	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-4031-0	Warfarin Sodium	10 in 1 BLISTER PACK	TABLET	10	14
51672-4031-0	Warfarin Sodium	10 in 1 CARTON	TABLET	10	14
51672-4031-1	Warfarin Sodium	100 in 1 BOTTLE	TABLET	100	14
51672-4031-3	Warfarin Sodium	1000 in 1 BOTTLE	TABLET	1000	14
51672-4031-7	Warfarin Sodium	5000 in 1 BOTTLE	TABLET	5000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4031-1	EA - Each	51672-4031	4b6beccb-4418-43cf-b8ed-cd8bc68a1d29	1	2012-07-24
51672-4031-3	EA - Each	51672-4031	ee68b21a-50a3-4315-a10c-8622b87bee24	1	2012-07-24
51672-4031-7	EA - Each	51672-4031	3c59749c-c230-4bbd-bc84-1abbd2d6505e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Warfarin Sodium	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
Warfarin	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
Barium Oxide	INACTIVE INGREDIENT	77603K202B	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3
Warfarin Sodium	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
Warfarin	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
Barium Oxide	INACTIVE INGREDIENT	77603K202B	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4031	WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	13	Current NDC, Legacy NDC, 5 package rows	20231222_8ad881e0-ca41-42ad-9d7d-eb85b3a30af0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6153CWM0CL	WARFARIN SODIUM	129-06-6	WARFARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855288	warfarin sodium 1 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855296	warfarin sodium 10 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855302	warfarin sodium 2 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855312	warfarin sodium 2.5 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855318	warfarin sodium 3 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855324	warfarin sodium 4 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855332	warfarin sodium 5 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855338	warfarin sodium 6 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855288	warfarin sodium 1 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855296	warfarin sodium 10 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855302	warfarin sodium 2 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855312	warfarin sodium 2.5 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855318	warfarin sodium 3 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855324	warfarin sodium 4 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855332	warfarin sodium 5 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855338	warfarin sodium 6 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	14
855288	warfarin sodium 1 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855296	warfarin sodium 10 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855302	warfarin sodium 2 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855312	warfarin sodium 2.5 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855318	warfarin sodium 3 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855324	warfarin sodium 4 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855332	warfarin sodium 5 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855338	warfarin sodium 6 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855288	warfarin sodium 1 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855296	warfarin sodium 10 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855302	warfarin sodium 2 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855312	warfarin sodium 2.5 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855318	warfarin sodium 3 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855324	warfarin sodium 4 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855332	warfarin sodium 5 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855338	warfarin sodium 6 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	b1b766b1-0327-48cd-ab01-e85038cf365f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4031-7	51672403107	5000 TABLET in 1 BOTTLE (51672-4031-7)	5000 tablet	1999-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2025-06-10	HUMAN PRESCRIPTION DRUG LABEL	14
Warfarin Sodium	Med-Health Pharma, LLC	2012-01-20	HUMAN PRESCRIPTION DRUG LABEL	2