Nabumetone

Product NDC: 68462-359
11-digit product format: 684620359
Labeler code: 68462
Product ID: 68462-359_53eb632a-bd56-4079-b1cd-c0699b9bfc52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078671
Marketing category: ANDA
Marketing start: 2008-03-01
Marketing end: 0000-00-00
Substance: NABUMETONE
Active strength: 750 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5	Product name	4	20251024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-359-01	EA - Each	68462-359	b492d302-6bf7-4203-8cde-d91ab77b2e58	1	2012-07-24
68462-359-05	EA - Each	68462-359	a8497a4e-5873-45a5-9103-8af51e9c9b1c	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 [BLENHEIM PHARMACAL, INC.]	5
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	5
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
POLYETHYLENE GLYCOL 200	INACTIVE INGREDIENT	R95B8J264J	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [RXCHANGE CO.]	1

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	a521e63f-9021-41a6-8f41-907b16caadd2	5
311893	nabumetone 750 MG Oral Tablet	PSN	a521e63f-9021-41a6-8f41-907b16caadd2	5
311892	nabumetone 500 MG Oral Tablet	SCD	a521e63f-9021-41a6-8f41-907b16caadd2	5
311893	nabumetone 750 MG Oral Tablet	SCD	a521e63f-9021-41a6-8f41-907b16caadd2	5
311893	nabumetone 750 MG Oral Tablet	PSN	1c6ea763-40f0-0cc9-e054-00144ff8d46c	3
311893	nabumetone 750 MG Oral Tablet	SCD	1c6ea763-40f0-0cc9-e054-00144ff8d46c	3
311892	nabumetone 500 MG Oral Tablet	PSN	87028b13-0aab-4e90-b92e-6b0c54e59bbb	2
311892	nabumetone 500 MG Oral Tablet	PSN	b52901fa-5f7e-418b-aae5-842da7610434	2
311893	nabumetone 750 MG Oral Tablet	PSN	87028b13-0aab-4e90-b92e-6b0c54e59bbb	2
311893	nabumetone 750 MG Oral Tablet	PSN	8c3ee7c0-02cb-1632-e053-2995a90ad4da	2
311893	nabumetone 750 MG Oral Tablet	PSN	b52901fa-5f7e-418b-aae5-842da7610434	2
311892	nabumetone 500 MG Oral Tablet	SCD	87028b13-0aab-4e90-b92e-6b0c54e59bbb	2
311892	nabumetone 500 MG Oral Tablet	SCD	b52901fa-5f7e-418b-aae5-842da7610434	2
311893	nabumetone 750 MG Oral Tablet	SCD	8c3ee7c0-02cb-1632-e053-2995a90ad4da	2
311893	nabumetone 750 MG Oral Tablet	SCD	87028b13-0aab-4e90-b92e-6b0c54e59bbb	2
311893	nabumetone 750 MG Oral Tablet	SCD	b52901fa-5f7e-418b-aae5-842da7610434	2
311892	nabumetone 500 MG Oral Tablet	PSN	e6a40890-d3ce-400c-a552-0d5ad28193c5	1
311893	nabumetone 750 MG Oral Tablet	PSN	e6a40890-d3ce-400c-a552-0d5ad28193c5	1
311893	nabumetone 750 MG Oral Tablet	PSN	11e2e5bf-c5bf-46db-920a-93711827aa5e	1
311893	nabumetone 750 MG Oral Tablet	PSN	fcf0a35b-1679-4c13-abde-7afc7d560484	1
311893	nabumetone 750 MG Oral Tablet	PSN	90b6d62f-6684-73bc-e053-2995a90a1a75	1
311893	nabumetone 750 MG Oral Tablet	PSN	90a2e268-bee6-498d-e053-2995a90ad52b	1
311892	nabumetone 500 MG Oral Tablet	SCD	e6a40890-d3ce-400c-a552-0d5ad28193c5	1
311893	nabumetone 750 MG Oral Tablet	SCD	90b6d62f-6684-73bc-e053-2995a90a1a75	1
311893	nabumetone 750 MG Oral Tablet	SCD	e6a40890-d3ce-400c-a552-0d5ad28193c5	1
311893	nabumetone 750 MG Oral Tablet	SCD	90a2e268-bee6-498d-e053-2995a90ad52b	1
311893	nabumetone 750 MG Oral Tablet	SCD	11e2e5bf-c5bf-46db-920a-93711827aa5e	1
311893	nabumetone 750 MG Oral Tablet	SCD	fcf0a35b-1679-4c13-abde-7afc7d560484	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-359-01	68462035901	100 TABLET, FILM COATED in 1 BOTTLE (68462-359-01)	2008-03-01	0000-00-00	No	No	Current
68462-359-05	68462035905	500 TABLET, FILM COATED in 1 BOTTLE (68462-359-05)	2008-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-10-06	HUMAN PRESCRIPTION DRUG LABEL	2
Nabumetone Tablets USP	Medsource Pharmaceuticals	2019-11-10	HUMAN PRESCRIPTION DRUG LABEL	3
NABUMETONE	Direct_Rx	2019-08-22	HUMAN PRESCRIPTION DRUG LABEL	1
NABUMETONE	Direct_Rx	2019-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
Nabumetone Tablets USP	Blenheim Pharmacal, Inc.	2015-05-27	HUMAN PRESCRIPTION DRUG LABEL	5
Nabumetone Tablets USP	RxChange Co.	2014-11-13	HUMAN PRESCRIPTION DRUG LABEL	1
Nabumetone Tablets USP	Aidarex Pharmaceuticals LLC	2014-01-16	HUMAN PRESCRIPTION DRUG LABEL	1
Nabumetone Tablets USP	Physicians Total Care, Inc.	2012-04-02	HUMAN PRESCRIPTION DRUG LABEL	2
Nabumetone Tablets USP	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
Nabumetone Tablets USP	Rebel Distributors Corp.	2010-10-08	HUMAN PRESCRIPTION DRUG LABEL	2

Nabumetone

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#