GEMFIBROZIL
- Product NDC
- 51013-811
- 11-digit product format
- 510130811
- Labeler code
- 51013
- Product ID
- 51013-811_4520735b-6858-4e3a-9ae5-d8d021b8d53b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMFIBROZIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical, LLC
- Application
- ANDA078012
- Marketing category
- ANDA
- Marketing start
- 2018-06-04
- 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