Nabumetone

Product NDC: 70518-4047
Requested package NDC: 70518-4047-1
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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A078420-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078420-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078420-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078420-002	AB	1	`782e0a99824c…`

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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Preferred Pharmaceuticals, Inc.	95769e02-fa4a-4389-a2fa-3146eae02526	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Preferred Pharmaceuticals Inc.	455c9992-39a0-4353-a121-57e700c77942	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	95aa8124-08fe-ff2f-e053-2a95a90a3c8f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	REMEDYREPACK INC.	311ae656-55d2-4116-a1bd-6f4a4ce70185	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	St. Mary's Medical Park Pharmacy	94930125-b792-579e-e053-2995a90ab6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	REMEDYREPACK INC.	6106afa3-e138-4b4d-8c13-992bf5062097	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (package): 70518-4047-1 ndc (product): 70518-4047 ndc11 (package): 70518404701
Nabumetone	NABUMETONE	Northwind Health Company, LLC	d9ca2484-7293-7db6-e053-2995a90a0f13	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Northwind Health Company, LLC	da34003b-81a4-2efd-e053-2995a90a961c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Redpharm Drug	3745775e-e11a-01db-e063-6294a90a9b52	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	75c51686-9c5e-4c13-acf4-2d04502eedda	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	583602ff-dbbe-4369-afa9-b917734ac9b1	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	b2a41c0b-e2ad-4e14-a2f7-2049c12c35da	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	ad9f2a34-6244-49b7-98ee-af18cb55693c	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	06f73fa8-7a8f-4160-939e-a25980a11906	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5a66c21f-4f06-4fb8-98fa-e81949586afd	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	419c597f-6a6f-4420-b240-7dc4c223387e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	a4553637-498e-491a-982a-cff81b43aa6c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	5ba602e9-846e-42b3-9ea6-fb461a948947	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0be7ee60-2706-43ed-98ec-b89cd4e2b57c	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
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

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
70518-4047-1	70518404701	60 TABLET in 1 BOTTLE, PLASTIC (70518-4047-1)	60 tablet	2024-05-16	No	No	Current