Warfarin Sodium

Product NDC: 51655-620
11-digit product format: 516550620
Labeler code: 51655
Product ID: 51655-620_4b81033f-d891-feb5-e063-6394a90a7538
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA040616
Marketing category: ANDA
Marketing start: 2023-01-03
Substance: WARFARIN SODIUM
Active strength: 1 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 10 · 378 observed 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
2026-08-18 06:07:40	2026-07	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040616-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040616-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040616-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040616-004	AB	1	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: Warfarin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WARFARIN SODIUM	1 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
855288	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
f32d3578-0c90-567c-e053-2a95a90a23b8	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-620-52	2026-01-29	C162847	48780-1	49896155-a98c-586f-e063-e6dba90add90	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 use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-620-52	Warfarin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-620	WARFARIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20230321_f32d3578-0c90-567c-e053-2a95a90a23b8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ndc (product): 51655-620
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

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	f32d3578-0c90-567c-e053-2a95a90a23b8	4
855288	warfarin sodium 1 MG Oral Tablet	SCD	f32d3578-0c90-567c-e053-2a95a90a23b8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-620-52	51655062052	30 TABLET in 1 BOTTLE, PLASTIC (51655-620-52)	30 tablet	2023-01-03	No	No	Current