COUMADIN

Product NDC: 43353-492
11-digit product format: 433530492
Labeler code: 43353
Product ID: 43353-492_6e052f18-f7a6-4e8b-9222-0a12572960b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: warfarin sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: NDA009218
Marketing category: NDA
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 3 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	43353-492		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-492	43353-492-30	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-492	43353-492-60	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 2 · 63 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	43353-492-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-492-60	`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	43353-492-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-492-60	`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	43353-492-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-492-60	`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	43353-492-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-492-60	`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	43353-492-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-492-60	`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	43353-492-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-492-60	`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	43353-492-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-492-60	`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	43353-492-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-492-60	`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	43353-492-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-492-60	`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	43353-492-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-492-60	`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	43353-492-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-492-60	`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	43353-492-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-492-60	`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	43353-492-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-492-60	`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	43353-492-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-492-60	`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	43353-492-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-492-60	`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	43353-492-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-492-60	`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	43353-492-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-492-60	`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	43353-492-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-492-60	`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	43353-492-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-492-60	`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	43353-492-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-492-60	`e2bbac7714bc…`	`27bdfed8d636…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1	Product name	1	20201123
85bed648-23ca-4804-98e6-e36aee999cad	Product name	1	20190717
80de93b4-8a94-428d-beb7-d644353ee70b	Product name	1	20180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688	Product name	1	20170522
db8eb201-78c7-4590-8a71-fac0a539bd8c	Product name	1	20170404
141092be-5eb5-452e-9f69-2d350aa70a87	Product name	1	20161208
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
43353-492-30	2020-01-31	C162847	48780-1	9d75b9cf-d58f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
43353-492-60	2020-01-31	C162847	48780-1	9d75b9cf-d58f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-492-30	COUMADIN	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
43353-492-60	COUMADIN	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-492-30	EA - Each	43353-492	4654e731-bb67-4596-a475-93023f60cbac	1	2012-07-24
43353-492-60	EA - Each	43353-492	ccad9432-51c2-4713-bd20-768732c77240	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-492	COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2	Legacy NDC, 2 package rows	20120815_ba41b963-ec4a-4421-ac93-26654876a6be.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
855290	Coumadin 1 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855298	Coumadin 10 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855320	Coumadin 3 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855346	Coumadin 7.5 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855288	warfarin sodium 1 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855296	warfarin sodium 10 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855318	warfarin sodium 3 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	ba41b963-ec4a-4421-ac93-26654876a6be	2
855290	warfarin sodium 1 MG Oral Tablet [Coumadin]	SBD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855298	warfarin sodium 10 MG Oral Tablet [Coumadin]	SBD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855320	warfarin sodium 3 MG Oral Tablet [Coumadin]	SBD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855346	warfarin sodium 7.5 MG Oral Tablet [Coumadin]	SBD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855288	warfarin sodium 1 MG Oral Tablet	SCD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855296	warfarin sodium 10 MG Oral Tablet	SCD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855318	warfarin sodium 3 MG Oral Tablet	SCD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	ba41b963-ec4a-4421-ac93-26654876a6be	2
855290	Coumadin 1 MG Oral Tablet	SY	ba41b963-ec4a-4421-ac93-26654876a6be	2
855298	Coumadin 10 MG Oral Tablet	SY	ba41b963-ec4a-4421-ac93-26654876a6be	2
855320	Coumadin 3 MG Oral Tablet	SY	ba41b963-ec4a-4421-ac93-26654876a6be	2
855346	Coumadin 7.5 MG Oral Tablet	SY	ba41b963-ec4a-4421-ac93-26654876a6be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-492-30	43353049230	30 in 1 BOTTLE, PLASTIC	Historical
43353-492-60	43353049260	90 in 1 BOTTLE, PLASTIC	Historical