Gemfibrozil

Product NDC: 66336-367
11-digit product format: 663360367
Labeler code: 66336
Product ID: 66336-367_b8ad55d8-697c-4859-b1b9-56e2c7ee8260
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA077836
Marketing category: ANDA
Marketing start: 2006-07-27
Marketing end: 0000-00-00
Substance: GEMFIBROZIL
Active strength: 600 mg/1
Pharmacologic classes: Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [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
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66336-367-30	2020-01-31	C162847	48780-1	9d75b9d0-2eb1-f424-e053-dadaa90a57ce	Gemfibrozil Tablets, USP Rev. 12/10

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-367-30	Gemfibrozil	30 in 1 BOTTLE	TABLET	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GEMFIBROZIL	ACTIVE INGREDIENT	Q8X02027X3	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
GEMFIBROZIL	ACTIVE MOIETY	Q8X02027X3	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
METHYLCELLULOSE (1500 MPA.S)	INACTIVE INGREDIENT	P0NTE48364	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-367	GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20120929_244f3a69-8539-46a3-9483-559af1fe17b2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q8X02027X3	GEMFIBROZIL	25812-30-0	GEMFIBROZIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	244f3a69-8539-46a3-9483-559af1fe17b2	2
310459	gemfibrozil 600 MG Oral Tablet	SCD	244f3a69-8539-46a3-9483-559af1fe17b2	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-367-30	66336036730	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP Rev. 12/10	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-28	HUMAN PRESCRIPTION DRUG LABEL	2