GEMFIBROZIL
- Product NDC
- 82804-221
- 11-digit product format
- 828040221
- Labeler code
- 82804
- Product ID
- 82804-221_e52c9c88-8197-48b4-88cb-1b4b22ceaf16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 |
|---|
| 82804-221-90 | 82804022190 | 90 TABLET in 1 BOTTLE (82804-221-90) | 90 tablet | 2025-04-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gemfibrozil Tablets, USP | Proficient Rx LP | 2025-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |