Nabumetone

Product NDC: 50090-0800
Requested package NDC: 50090-0800-0
11-digit product format: 500900800
Labeler code: 50090
Product ID: 50090-0800_f0b56baf-2fd9-4115-ba2b-b71904360e8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA091083
Marketing category: ANDA
Marketing start: 2011-06-13
Marketing end: 0000-00-00
Substance: NABUMETONE
Active strength: 750 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: 2022-12-31
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	50090-0800	50090-0800-0	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 1 · 15 matching rows.

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

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

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 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
50090-0800-0	Nabumetone Tablets, USP Rx Only
50090-0800-2	Nabumetone Tablets, USP Rx Only
50090-0800-3	Nabumetone Tablets, USP Rx Only
50090-0800-4	Nabumetone Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0800-0	Nabumetone	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
50090-0800-2	Nabumetone	14 in 1 BOTTLE	TABLET, FILM COATED	14	14
50090-0800-3	Nabumetone	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
50090-0800-4	Nabumetone	20 in 1 BOTTLE	TABLET, FILM COATED	20	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0800-0	EA - Each	50090-0800	8367b58a-c77a-46ed-b528-f5966fbd517c	1	2018-10-11
50090-0800-2	EA - Each	50090-0800	b6de8b37-e7ee-4406-8fbd-55f04bee8247	1	2018-10-11
50090-0800-3	EA - Each	50090-0800	75ee1d68-0399-4e56-9461-0eef7537d855	1	2018-10-11
50090-0800-4	EA - Each	50090-0800	b489d53b-2b76-44f5-932b-abe87554bf78	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0800	NABUMETONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	14	Legacy NDC, 4 package rows	20210616_466f4261-4b7c-4502-9f00-8d0c7e46ac89.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311893	nabumetone 750 MG Oral Tablet	PSN	466f4261-4b7c-4502-9f00-8d0c7e46ac89	14
311893	nabumetone 750 MG Oral Tablet	SCD	466f4261-4b7c-4502-9f00-8d0c7e46ac89	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0800-0	50090080000	30 TABLET, FILM COATED in 1 BOTTLE (50090-0800-0)	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets, USP Rx Only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	14