Warfarin Sodium

Product NDC: 71335-1059
Requested package NDC: 71335-1059-3
11-digit product format: 713351059
Labeler code: 71335
Product ID: 71335-1059_d6962c17-e2cc-4af2-be28-dfd75796b4bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040616
Marketing category: ANDA
Marketing start: 2018-08-27
Substance: WARFARIN SODIUM
Active strength: 7.5 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	RLD / RS	Approval date
A040616-001	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05
A040616-002	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05
A040616-003	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05
A040616-004	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05
A040616-005	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05
A040616-006	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05
A040616-007	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05
A040616-008	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05
A040616-009	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040616-001	AB
A040616-002	AB
A040616-003	AB
A040616-004	AB
A040616-005	AB
A040616-006	AB
A040616-007	AB
A040616-008	AB
A040616-009	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`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	A040616-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040616-009	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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	724b0061-f42a-4008-a078-09c800ee9785	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	f5fb1a5f-0dda-4f47-8683-ea63ac88a69d	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	1244c338-9140-425a-bf2a-9da6b4ac0287	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	d6083d68-4360-4d47-a1b2-1eb2763024bb	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	4dc2d94e-f856-47da-9d44-24773d97eb87	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	ba65ae56-ca3b-4895-9938-1dde2c3d34bf	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	3f1c3083-91d1-488c-ad07-b198fda21da6	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	748ebea5-c65b-4b5a-b237-f4eb880865fa	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	b1bd0d02-eccb-4449-82b9-9b552835029e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32d3578-0c90-567c-e053-2a95a90a23b8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32dd451-3f7a-815b-e053-2995a90a528f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f86fe457-a1b6-e54d-e053-6294a90a9bc7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	3aeb6bb1-bc43-4fe7-83f2-36cd0bf46102	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	8eae6b6c-1851-4342-b320-7e1896894658	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	a1860448-d4ef-40f2-b096-056429ca3aea	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	d166f83b-7052-4dc7-b7d4-47faae7dcaed	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	e7f78a33-71eb-4aac-ba9d-70f75136fab0	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	PD-Rx Pharmaceuticals, Inc.	21255cd5-3c2e-4574-9620-9347d14256b3	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	4f8afe14-897c-458b-b76f-9bae6fa6110e	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	44077bb7-6007-4c15-bbcd-a7a02ac081ce	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616

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	7.5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7f604dc4-c2cd-4b1f-b94d-b5877a1be66b	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
71335-1059-1	Warfarin Sodium	30 in 1 BOTTLE	TABLET	30	6
71335-1059-2	Warfarin Sodium	90 in 1 BOTTLE	TABLET	90	6
71335-1059-3	Warfarin Sodium	15 in 1 BOTTLE	TABLET	15	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1059	WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 3 package rows	20231110_7f604dc4-c2cd-4b1f-b94d-b5877a1be66b.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
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	7f604dc4-c2cd-4b1f-b94d-b5877a1be66b	6
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	7f604dc4-c2cd-4b1f-b94d-b5877a1be66b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1059-3	71335105903	15 TABLET in 1 BOTTLE (71335-1059-3)	15 tablet	2022-02-09	0000-00-00	No	No	Current