Nabumetone

Product NDC: 60687-374
11-digit product format: 606870374
Labeler code: 60687
Product ID: 60687-374_c7b7ff53-4af4-7a94-e053-2995a90a5261
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA091083
Marketing category: ANDA
Marketing start: 2019-02-14
Marketing end: 2021-11-30
Substance: NABUMETONE
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	60687-374		D	Discontinued by firm		2026-08-17
excluded package	package	60687-374	60687-374-01	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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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	60687-374-01	`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
A091083-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2011-06-13
A091083-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2011-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091083-001	AB
A091083-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`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	A091083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091083-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091083-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091083-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091083-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091083-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091083-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091083-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091083-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091083-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091083-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091083-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091083-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091083-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091083-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-374-01	EA - Each	60687-374	5f219666-834e-4e8e-bd0c-f701566efef6	1	2018-11-06
60687-374-11	EA - Each	60687-374	c4d646d2-85c9-4b81-9ad8-2b5bb9bf65d5	1	2018-11-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0186328f-3eb7-4407-bf9e-8007d08ebe7b	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Bryant Ranch Prepack	dd0d2652-d335-45db-af43-5a2523f7299a	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Actavis Pharma, Inc.	53656d70-6572-4669-6465-6c6973555341	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Proficient Rx LP	0870c3c9-bfce-4722-8779-8775644196d3	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Proficient Rx LP	079a8a9e-6d71-414a-83f3-ef68e323c1fd	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-374-01	60687037401	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-374-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-374-11)	100 blister pack	2019-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets, USP Rx Only 8437401/0418F	American Health Packaging	2021-07-22	HUMAN PRESCRIPTION DRUG LABEL	4