Nabumetone

Product NDC: 10544-003
11-digit product format: 105440003
Labeler code: 10544
Product ID: 10544-003_17114c5d-e704-0cbc-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA078671
Marketing category: ANDA
Marketing start: 2010-06-11
Marketing end: 0000-00-00
Substance: NABUMETONE
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-003		I	Inactivated by FDA	2026-08-17
excluded package	package	10544-003	10544-003-20	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-003	10544-003-30	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-003	10544-003-60	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-003	10544-003-90	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 · 110 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	10544-003-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-003-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-003-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-003-60	`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	10544-003-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-003-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-003-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-003-60	`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	10544-003-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-003-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-003-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-003-60	`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	10544-003-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-003-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-003-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-003-60	`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	10544-003-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-003-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-003-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-003-60	`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	10544-003-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-003-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-003-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-003-60	`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	10544-003-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-003-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-003-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-003-60	`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	10544-003-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-003-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-003-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-003-60	`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	10544-003-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-003-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-003-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-003-60	`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	10544-003-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-003-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-003-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-003-60	`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	10544-003-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-003-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-003-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-003-60	`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	10544-003-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-003-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-003-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-003-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078671-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07
A078671-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078671-001	AB
A078671-002	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 3 · 84 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	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078671-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5	Product name	4	20251024

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
10544-003-20	Nabumetone Tablets USP
10544-003-30	Nabumetone Tablets USP
10544-003-60	Nabumetone Tablets USP
10544-003-90	Nabumetone Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-003-20	Nabumetone	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
10544-003-30	Nabumetone	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
10544-003-60	Nabumetone	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
10544-003-90	Nabumetone	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-003-20	EA - Each	10544-003	9a84a798-4f18-4507-8314-929c5c435b2e	1	2015-10-02
10544-003-60	EA - Each	10544-003	08917308-0b9d-404f-84e8-a778ca1adcdc	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-003	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5	Legacy NDC, 4 package rows	20150527_a521e63f-9021-41a6-8f41-907b16caadd2.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Northwind Health Company, LLC	b088f564-43ff-8007-e053-2995a90ab012	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	American Health Packaging	0653b873-b74b-4ec6-b112-675760703d91	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	8f3c1b1d-2765-4cb5-92df-044b99339c92	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Exelan Pharmaceuticals Inc.	16e76e29-9315-40c0-b1d6-8d91961063cf	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Cipla USA Inc.	85954380-a520-46d7-89ac-e4b19d6e00a1	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9969df-ce14-c0bc-e053-2995a90a3f59	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LW0TIW155Z	NABUMETONE	42924-53-8	NABUMETONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311892	nabumetone 500 MG Oral Tablet	PSN	a521e63f-9021-41a6-8f41-907b16caadd2	5
311893	nabumetone 750 MG Oral Tablet	PSN	a521e63f-9021-41a6-8f41-907b16caadd2	5
311892	nabumetone 500 MG Oral Tablet	SCD	a521e63f-9021-41a6-8f41-907b16caadd2	5
311893	nabumetone 750 MG Oral Tablet	SCD	a521e63f-9021-41a6-8f41-907b16caadd2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-003-20	10544000320	20 in 1 BOTTLE	Historical
10544-003-30	10544000330	30 in 1 BOTTLE	Historical
10544-003-60	10544000360	60 in 1 BOTTLE	Historical
10544-003-90	10544000390	90 in 1 BOTTLE	Historical