Nabumetone

Product NDC: 43063-972
11-digit product format: 430630972
Labeler code: 43063
Product ID: 43063-972_36c31358-008c-bd73-e063-6294a90a06cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078671
Marketing category: ANDA
Marketing start: 2019-03-06
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
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A078671-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07
A078671-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078671-001	AB
A078671-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`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	A078671-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nabumetone
Listing expiration: 2026-12-31

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
8f3c1b1d-2765-4cb5-92df-044b99339c92	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
43063-972-20	Nabumetone	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20		10
43063-972-30	Nabumetone	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-972-20	EA - Each	43063-972	3a555ac3-62eb-45d6-bd16-f8278752ef3a	1	2019-06-19
43063-972-30	EA - Each	43063-972	9a27a891-9b50-46a1-a22b-9eaa7ef39252	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-972	NABUMETONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20241018_8f3c1b1d-2765-4cb5-92df-044b99339c92.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Northwind Health Company, LLC	b088f564-43ff-8007-e053-2995a90ab012	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	American Health Packaging	0653b873-b74b-4ec6-b112-675760703d91	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	8f3c1b1d-2765-4cb5-92df-044b99339c92	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671 ndc (product): 43063-972
Nabumetone	NABUMETONE	Exelan Pharmaceuticals Inc.	16e76e29-9315-40c0-b1d6-8d91961063cf	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Cipla USA Inc.	85954380-a520-46d7-89ac-e4b19d6e00a1	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9969df-ce14-c0bc-e053-2995a90a3f59	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671

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	8f3c1b1d-2765-4cb5-92df-044b99339c92	10
311892	nabumetone 500 MG Oral Tablet	SCD	8f3c1b1d-2765-4cb5-92df-044b99339c92	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-972-20	43063097220	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-972-20)	2019-04-22	0000-00-00	No	No	Current
43063-972-30	43063097230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-972-30)	2019-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-06-04	HUMAN PRESCRIPTION DRUG LABEL	10