Gemfibrozil
- Product NDC
- 59115-094
- 11-digit product format
- 591150094
- Labeler code
- 59115
- Product ID
- 59115-094_aadcb922-465a-41ee-8a0c-949a7bf71cca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceutical
- Application
- ANDA078599
- Marketing category
- ANDA
- Marketing start
- 2010-08-16
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record