Gemfibrozil

Product NDC

53808-0863

11-digit product format

538080863

Labeler code

53808

Product ID

53808-0863_9ae2f08d-e20b-46e3-b0f8-67118a65f662

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gemfibrozil

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

State of Florida DOH Central Pharmacy

Application

ANDA078012

Marketing category

ANDA

Marketing start

2013-01-01

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record