Nabumetone

Product NDC: 55700-845
11-digit product format: 557000845
Labeler code: 55700
Product ID: 55700-845_273dcba6-29a0-47f9-83b4-04d1e692232e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA078420
Marketing category: ANDA
Marketing start: 2020-02-28
Marketing end: 2027-03-31
Substance: NABUMETONE
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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	55700-845	55700-845-30	D	Discontinued by firm		2026-10-05

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 · 9 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078420-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-09-24
A078420-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2008-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078420-001	AB
A078420-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078420-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078420-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078420-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nabumetone

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NABUMETONE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LW0TIW155Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311892	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
065fdacc-739e-4b46-bebc-044b5c11bbbb	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55700-845-30	Nabumetone	30 in 1 BOTTLE	TABLET	30		6
55700-845-60	Nabumetone	60 in 1 BOTTLE	TABLET	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-845-30	EA - Each	55700-845	65a014e7-fe22-4401-ae39-c9135f31eaee	1	2020-04-20
55700-845-60	EA - Each	55700-845	2f762786-ce06-4293-b4e2-4549cfd1c208	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-845	NABUMETONE TABLET [QUALITY CARE PRODUCTS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241220_065fdacc-739e-4b46-bebc-044b5c11bbbb.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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	69620c53-b37a-45b9-b560-221bbcd98fda	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
NABUMETONE	NABUMETONE	direct rx	a8600b12-f180-0b27-e053-2995a90acbd9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	ScieGen Pharmaceuticals Inc	80c6888d-03b4-44f3-b94d-bcf5154ceae5	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9994ac-6687-2df2-e053-2995a90a959a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Advanced Rx Pharmacy of Tennessee, LLC	b43db4aa-6013-3942-e053-2a95a90a5189	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Quality Care Products, LLC	da259c7c-6f1e-403c-b42b-596d53b61fe5	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Quality Care Products, LLC	065fdacc-739e-4b46-bebc-044b5c11bbbb	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (product): 55700-845
Nabumetone	NABUMETONE	A-S Medication Solutions	26037234-daca-4f1a-a7a7-0871f77283f0	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	A-S Medication Solutions	d997d125-dfc5-4cc5-b7a6-03f5a7248d14	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Westminster Pharmaceuticals, LLC	264df44a-e294-4d9b-9113-92859cb08c20	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	62f2e0bf-e5c8-480c-ac5e-401ced3bbc67	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Proficient Rx LP	7a1643bf-6627-4b12-8246-6acc40517cf2	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Proficient Rx LP	f4392863-ed3f-4fbd-8260-49827609aa2e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Asclemed USA, Inc.	04a71deb-2c9d-436c-a574-e5991b6a5248	2022-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420

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	065fdacc-739e-4b46-bebc-044b5c11bbbb	6
311892	nabumetone 500 MG Oral Tablet	SCD	065fdacc-739e-4b46-bebc-044b5c11bbbb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-845-30	55700084530	30 TABLET in 1 BOTTLE (55700-845-30)	30 tablet	2020-02-28	0000-00-00	No	No	Current
55700-845-60	55700084560	60 TABLET in 1 BOTTLE (55700-845-60)	60 tablet	2020-02-28	2027-03-31	No	No	Current