Warfarin Sodium

Product NDC: 50090-5004
11-digit product format: 500905004
Labeler code: 50090
Product ID: 50090-5004_776ea037-7f84-43d0-ade4-55e8a70ef9bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040616
Marketing category: ANDA
Marketing start: 2018-08-27
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 8 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-5004		D	Discontinued by firm	2026-10-15
excluded package	package	50090-5004	50090-5004-0	D	Discontinued by firm	2026-10-15
excluded package	package	50090-5004	50090-5004-1	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	50090-5004		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5004	50090-5004-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5004	50090-5004-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 396 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
2026-10-15 13:18:30	2026-09	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A040616-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-006	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-007	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-008	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040616-009	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040616-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-008	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-009	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Effective	Related label
50090-5004-0	2023-02-07	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
50090-5004-1	2023-02-07	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
50090-5004-0	2023-01-30	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
50090-5004-1	2023-01-30	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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5004	WARFARIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]	6	Legacy NDC	20230208_b2728b7c-ae6e-49f6-b21b-335db78f4c49.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 2 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	Bryant Ranch Prepack	7f604dc4-c2cd-4b1f-b94d-b5877a1be66b	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Teva Pharmaceuticals USA, Inc.	0cbce382-9c88-4f58-ae0f-532a841e8f95	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	53a6947e-ef3f-403b-9ccc-1740ae5efad0	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	5a7d347b-391e-4e9b-a691-1962c7da4fc7	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	35bf53df-994b-4c32-8bdb-9227e8e195c6	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Proficient Rx LP	388bfa49-f4f7-412a-80ff-d09442489e2b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Proficient Rx LP	73048ed9-242f-4f86-a8db-9c7547daa01d	2020-05-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5004-0	50090500400	30 TABLET in 1 BOTTLE (50090-5004-0)	30 tablet	2020-04-14	0000-00-00	No	No	Current
50090-5004-1	50090500401	90 TABLET in 1 BOTTLE (50090-5004-1)	90 tablet	2020-04-14	0000-00-00	No	No	Current