COUMADIN

Product NDC: 55154-7704
11-digit product format: 551547704
Labeler code: 55154
Product ID: 55154-7704_a8ffee52-e235-4af4-a25a-d4dc30b57f3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: warfarin sodium
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health
Application: NDA009218
Marketing category: NDA
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 5 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	55154-7704		D	Discontinued by firm		2026-08-17
excluded package	package	55154-7704	55154-7704-0	D	Discontinued by firm		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 · 24 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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`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	55154-7704-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N009218-005	COUMADIN	WARFARIN SODIUM	10MG	TABLET / ORAL	RLD, Approved before 1982
N009218-007	COUMADIN	WARFARIN SODIUM	5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-012	COUMADIN	WARFARIN SODIUM	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N009218-013	COUMADIN	WARFARIN SODIUM	2MG	TABLET / ORAL	RLD, Approved before 1982
N009218-016	COUMADIN	WARFARIN SODIUM	7.5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-018	COUMADIN	WARFARIN SODIUM	2.5MG	TABLET / ORAL	RLD, Approved before 1982
N009218-020	COUMADIN	WARFARIN SODIUM	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982
N009218-022	COUMADIN	WARFARIN SODIUM	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01
N009218-023	COUMADIN	WARFARIN SODIUM	4MG	TABLET / ORAL	RLD	1993-08-24
N009218-024	COUMADIN	WARFARIN SODIUM	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07
N009218-025	COUMADIN	WARFARIN SODIUM	3MG	TABLET / ORAL	RLD	1996-11-18
N009218-026	COUMADIN	WARFARIN SODIUM	6MG	TABLET / ORAL	RLD	1996-11-18

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 13 · 504 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-016	COUMADIN	7.5MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-018	COUMADIN	2.5MG	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-020	COUMADIN	50MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-022	COUMADIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-023	COUMADIN	4MG	TABLET / ORAL	RLD	1993-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-024	COUMADIN	5MG/VIAL	INJECTABLE / INJECTION		1995-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-025	COUMADIN	3MG	TABLET / ORAL	RLD	1996-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009218-026	COUMADIN	6MG	TABLET / ORAL	RLD	1996-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009218-005	COUMADIN	10MG	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009218-007	COUMADIN	5MG	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009218-012	COUMADIN	75MG/VIAL	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009218-013	COUMADIN	2MG	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N009218-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-007	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-013	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-016	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-018	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-022	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-023	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-025	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009218-026	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N009218-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-007	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-013	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-016	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-018	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-022	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-023	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-025	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009218-026	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009218-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-007	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-013	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-016	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-018	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-022	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-023	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-025	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009218-026	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009218-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-007	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-013	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-016	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-018	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-022	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-023	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-025	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009218-026	AB	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
warfarin sodium	ACTIVE INGREDIENT	6153CWM0CL	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
warfarin	ACTIVE MOIETY	5Q7ZVV76EI	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
aluminum hydroxide	INACTIVE INGREDIENT	5QB0T2IUN0	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
barium sulfate	INACTIVE INGREDIENT	25BB7EKE2E	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
lactose	INACTIVE INGREDIENT	J2B2A4N98G	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8
starch, tapioca	INACTIVE INGREDIENT	24SC3U704I	COUMADIN (WARFARIN SODIUM) TABLET [CARDINAL HEALTH]	8

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
55154-7704-0	55154770400	10 BLISTER PACK in 1 BAG (55154-7704-0) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2009-01-01	0000-00-00	No	No	Current