Gemfibrozil
- Product NDC
- 71335-1902
- 11-digit product format
- 713351902
- Labeler code
- 71335
- Product ID
- 71335-1902_be2e589c-9e89-462a-844a-d3617a68a8d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203266
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Q8X02027X3 | GEMFIBROZIL | 25812-30-0 | GEMFIBROZIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1902-1 | 71335190201 | 60 TABLET in 1 BOTTLE (71335-1902-1) | 60 tablet | 2021-07-13 | No | No | Historical |
| 71335-1902-2 | 71335190202 | 30 TABLET in 1 BOTTLE (71335-1902-2) | 30 tablet | 2021-08-03 | No | No | Historical |
| 71335-1902-3 | 71335190203 | 100 TABLET in 1 BOTTLE (71335-1902-3) | 100 tablet | 2022-03-10 | No | No | Historical |
| 71335-1902-4 | 71335190204 | 90 TABLET in 1 BOTTLE (71335-1902-4) | 90 tablet | 2022-03-10 | No | No | Historical |
| 71335-1902-5 | 71335190205 | 180 TABLET in 1 BOTTLE (71335-1902-5) | 180 tablet | 2021-09-13 | No | No | Historical |