GEMFIBROZIL
- Product NDC
- 71610-601
- 11-digit product format
- 716100601
- Labeler code
- 71610
- Product ID
- 71610-601_8cfd64d4-38e2-4c2c-97b0-9284da5fe6da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA214603
- Marketing category
- ANDA
- Marketing start
- 2021-01-20
- 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 |
|---|
| 71610-601-53 | 71610060153 | 60 TABLET in 1 BOTTLE (71610-601-53) | 60 tablet | 2021-10-19 | No | No | Historical |
| 71610-601-60 | 71610060160 | 90 TABLET in 1 BOTTLE (71610-601-60) | 90 tablet | 2021-10-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gemfibrozil Tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2021-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |