Nabumetone

Product NDC: 63629-7699
Requested package NDC: 63629-7699-3
11-digit product format: 636297699
Labeler code: 63629
Product ID: 63629-7699_b8764436-bb31-4c68-b832-f52ce68058e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091083
Marketing category: ANDA
Marketing start: 2011-06-13
Marketing end: 0000-00-00
Substance: NABUMETONE
Active strength: 750 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-7699	63629-7699-3	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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-7699-1	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-2	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-3	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-4	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-5	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-6	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-7	2025-09-05	Nabumetone Tablets, USP Rx only
63629-7699-1	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-2	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-3	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-4	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-5	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-6	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-7	2024-01-30	Nabumetone Tablets, USP Rx only
63629-7699-1	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-2	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-3	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-4	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-5	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-6	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-7	2020-10-16	Nabumetone Tablets, USP Rx only
63629-7699-1	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-2	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-3	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-4	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-5	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-6	2020-01-31	Nabumetone Tablets, USP Rx only
63629-7699-7	2020-01-31	Nabumetone Tablets, USP Rx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7699	NABUMETONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	6	Legacy NDC	20220507_3d46d6e6-9b06-45f8-a983-526005d75e69.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 · 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	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7699-3	63629769903	90 TABLET, FILM COATED in 1 BOTTLE (63629-7699-3)	2018-08-13	0000-00-00	No	No	Current