Nabumetone

Product NDC: 70518-4047
11-digit product format: 705184047
Labeler code: 70518
Product ID: 70518-4047_4b8435b5-6dbd-c6cf-e063-6394a90aec8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078420
Marketing category: ANDA
Marketing start: 2024-04-07
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: 2027-12-31
Current FDA listing: Yes

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NABUMETONE	750 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
311893	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
6106afa3-e138-4b4d-8c13-992bf5062097	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	SPL version
70518-4047-0	Nabumetone	14 in 1 BOTTLE, PLASTIC	TABLET	14	4
70518-4047-1	Nabumetone	60 in 1 BOTTLE, PLASTIC	TABLET	60	4
70518-4047-2	Nabumetone	60 in 1 BOTTLE, PLASTIC	TABLET	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4047	NABUMETONE TABLET [REMEDYREPACK INC.]	2	Current NDC, 3 package rows	20240517_6106afa3-e138-4b4d-8c13-992bf5062097.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
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
311893	nabumetone 750 MG Oral Tablet	PSN	6106afa3-e138-4b4d-8c13-992bf5062097	4
311893	nabumetone 750 MG Oral Tablet	SCD	6106afa3-e138-4b4d-8c13-992bf5062097	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4047-0	70518404700	14 TABLET in 1 BOTTLE, PLASTIC (70518-4047-0)	14 tablet	2024-04-07	No	No	Current
70518-4047-1	70518404701	60 TABLET in 1 BOTTLE, PLASTIC (70518-4047-1)	60 tablet	2024-05-16	No	No	Current
70518-4047-2	70518404702	60 TABLET in 1 BOTTLE, PLASTIC (70518-4047-2)	60 tablet	2026-02-23	No	No	Current