Warfarin Sodium

Product NDC: 51138-054
11-digit product format: 511380054
Labeler code: 51138
Product ID: 51138-054_e2447944-15e9-4074-aff0-2c90a7c04694
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: warfarin sodium
Dosage form: TABLET
Route: ORAL
Labeler: Med-Health Pharma, LLC
Application: ANDA040301
Marketing category: ANDA
Marketing start: 2011-02-09
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 1 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51138-054		I	Inactivated by FDA		2026-08-17
excluded package	package	51138-054	51138-054-30	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51138-054-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51138-054-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51138-054-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51138-054-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51138-054-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51138-054-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51138-054-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51138-054-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51138-054-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51138-054-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51138-054-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51138-054-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51138-054-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51138-054-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51138-054-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51138-054-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51138-054-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51138-054-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51138-054-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51138-054-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51138-054-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51138-054-30	`110d247fa046…`	`a55b01930146…`

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	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.

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`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	A040301-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040301-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040301-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-004	AB	1	`fd3edfee7708…`

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
51138-054-30	2019-11-13	C162847	48780-1	97449f38-c58d-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, 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
51138-054-30	Warfarin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51138-054-30	EA - Each	51138-054	f2f4a8a3-028f-4cad-ab02-48ae70311f61	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 [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
51138-054	WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]	2	Legacy NDC, 1 package rows	20120208_b1b766b1-0327-48cd-ab01-e85038cf365f.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	bd6ea120-5d1c-4815-94f2-81e28dc6b7a9	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
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
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

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	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	Status
51138-054-30	51138005430	30 in 1 BOTTLE, PLASTIC	Historical