Nabumetone

Product NDC: 66336-316
11-digit product format: 663360316
Labeler code: 66336
Product ID: 66336-316_4f00b5a8-165b-4081-99c7-a33bf3273416
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA078671
Marketing category: ANDA
Marketing start: 2008-03-01
Marketing end: 0000-00-00
Substance: NABUMETONE
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66336-316-30	2019-11-27	C162847	48780-1	9855d018-d2bc-cd31-e053-dbdaa90ab51a	Nabumetone Tablets USP

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-316-30	Nabumetone	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-316	NABUMETONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20130701_d6b3822b-8f14-4137-8d53-24863f4c605e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LW0TIW155Z	NABUMETONE	42924-53-8	NABUMETONE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311892	nabumetone 500 MG Oral Tablet	PSN	d6b3822b-8f14-4137-8d53-24863f4c605e	2
311892	nabumetone 500 MG Oral Tablet	SCD	d6b3822b-8f14-4137-8d53-24863f4c605e	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-316-30	66336031630	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-01	HUMAN PRESCRIPTION DRUG LABEL	2