Nabumetone

Product NDC: 0591-3670
Requested package NDC: 0591-3670-77
11-digit product format: 005913670
Labeler code: 0591
Product ID: 0591-3670_50a45f4a-452a-43d5-8f93-38b1023dec1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA091083
Marketing category: ANDA
Marketing start: 2011-06-13
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

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
unfinished package	package	0591-3670	0591-3670-77	UNFINISHED	Active or certified unfinished drug listing		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 · 11 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`

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…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311892	Internal RxNorm lookup
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
53656d70-6572-4669-6465-6c6973555341	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3670-01	Nabumetone	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		23
0591-3670-05	Nabumetone	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3670-01	EA - Each	0591-3670	909a86cf-03e5-400a-a046-70dc35c4f1cf	1	2012-07-24
0591-3670-05	EA - Each	0591-3670	3b0af267-9acf-4e4b-b192-c160495df4c0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [WATSON LABORATORIES, INC.]	6
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3670	NABUMETONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	22	Current NDC, Legacy NDC, 2 package rows	20250501_53656d70-6572-4669-6465-6c6973555341.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 ndc (product): 0591-3670
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
311892	nabumetone 500 MG Oral Tablet	PSN	53656d70-6572-4669-6465-6c6973555341	23
311893	nabumetone 750 MG Oral Tablet	PSN	53656d70-6572-4669-6465-6c6973555341	23
311892	nabumetone 500 MG Oral Tablet	SCD	53656d70-6572-4669-6465-6c6973555341	23
311893	nabumetone 750 MG Oral Tablet	SCD	53656d70-6572-4669-6465-6c6973555341	23
311892	nabumetone 500 MG Oral Tablet	PSN	b0982bef-c543-4ace-8d20-b90b2184e5fb	7
311892	nabumetone 500 MG Oral Tablet	SCD	b0982bef-c543-4ace-8d20-b90b2184e5fb	7
311892	nabumetone 500 MG Oral Tablet	PSN	0870c3c9-bfce-4722-8779-8775644196d3	5
311892	nabumetone 500 MG Oral Tablet	PSN	dd0d2652-d335-45db-af43-5a2523f7299a	5
311892	nabumetone 500 MG Oral Tablet	SCD	0870c3c9-bfce-4722-8779-8775644196d3	5
311892	nabumetone 500 MG Oral Tablet	SCD	dd0d2652-d335-45db-af43-5a2523f7299a	5
311892	nabumetone 500 MG Oral Tablet	PSN	ad87d83f-f10c-4804-aa27-6d9ecabc12d6	4
311892	nabumetone 500 MG Oral Tablet	SCD	ad87d83f-f10c-4804-aa27-6d9ecabc12d6	4
311892	nabumetone 500 MG Oral Tablet	PSN	2d8f206e-0853-43ca-e054-00144ff8d46c	3
311892	nabumetone 500 MG Oral Tablet	PSN	79a0d2b5-2e19-4513-b60c-b612906f0bce	3
311892	nabumetone 500 MG Oral Tablet	SCD	2d8f206e-0853-43ca-e054-00144ff8d46c	3
311892	nabumetone 500 MG Oral Tablet	SCD	79a0d2b5-2e19-4513-b60c-b612906f0bce	3
311892	nabumetone 500 MG Oral Tablet	PSN	08875d24-222c-4b1e-a88a-6e8575bb4eff	1
311892	nabumetone 500 MG Oral Tablet	SCD	08875d24-222c-4b1e-a88a-6e8575bb4eff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
0591-3670-77	00591367077	18180 TABLET, FILM COATED in 1 CONTAINER (0591-3670-77)	16-SEP-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets, USP Rx only	Bryant Ranch Prepack	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	5
Nabumetone Tablets, USP Rx only	Actavis Pharma, Inc.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	23
Nabumetone Tablets USP Rx Only	St. Mary's Medical Park Pharmacy	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	5
Nabumetone Tablets USP Rx Only	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	5
Nabumetone Tablets, USP Rx Only 8437401/0418F	American Health Packaging	2021-07-22	HUMAN PRESCRIPTION DRUG LABEL	4
Nabumetone Tablets, USP Rx Only	A-S Medication Solutions	2021-04-14	HUMAN PRESCRIPTION DRUG LABEL	7
Nabumetone Tablets USP Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Nabumetone Tablets USP Rx Only	Preferred Pharmaceuticals Inc.	2020-07-28	HUMAN PRESCRIPTION DRUG LABEL	3
NABUMETONE 500mg	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Nabumetone Tablets, USP Revised: December 2010 Rx only 195702	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	3919
Nabumetone Tablets USP Rx Only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Nabumetone Tablets, USP Revised: December 2010 Rx only 195702	Blenheim Pharmacal, Inc.	2015-07-31	HUMAN PRESCRIPTION DRUG LABEL	3
Nabumetone Tablets, USP Revised: December 2010 Rx only 195702	Aidarex Pharmaceuticals LLC	2014-01-16	HUMAN PRESCRIPTION DRUG LABEL	1