Nabumetone

Product NDC: 0591-3670
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

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 Identifiers#

Field, Values table
Field	Values
Unii	LW0TIW155Z
Rxcui	311892, 311893

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 [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

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	Marketing end	Sample	Exclude flag	Status
0591-3670-01	00591367001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-01)	2011-06-13	0000-00-00	No	No	Current
0591-3670-05	00591367005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-05)	2011-06-13	0000-00-00	No	No	Current
0591-3670-10	00591367010	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-10)	2011-06-13	0000-00-00	No	No	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	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	5
Nabumetone Tablets, USP Rx Only	A-S Medication Solutions	2021-04-14	HUMAN PRESCRIPTION DRUG LABEL	7
NABUMETONE 500mg	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
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

Nabumetone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#