Gemfibrozil
- Product NDC
- 62135-160
- 11-digit product format
- 621350160
- Labeler code
- 62135
- Product ID
- 62135-160_2589e155-f097-67fc-e063-6294a90a20b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA074270
- Marketing category
- ANDA
- Marketing start
- 1993-09-27
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-160-31 | 62135016031 | 300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31) | 2023-08-25 | No | No | Historical |
| 62135-160-60 | 62135016060 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-160-60) | 2023-08-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| GEMFIBROZIL TABLETS, USP | Chartwell RX, LLC | 2024-10-28 | HUMAN PRESCRIPTION DRUG LABEL | 3 |