Gemfibrozil
- Product NDC
- 71610-824
- 11-digit product format
- 716100824
- Labeler code
- 71610
- Product ID
- 71610-824_17529d33-f24b-1f3f-e063-6394a90ae374
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078012
- Marketing category
- ANDA
- Marketing start
- 2011-04-01
- 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 |
|---|
| 71610-824-30 | 71610082430 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-824-30) | 2024-04-29 | No | No | Historical |
| 71610-824-53 | 71610082453 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-824-53) | 2024-04-29 | No | No | Historical |
| 71610-824-60 | 71610082460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-824-60) | 2024-04-29 | No | No | Historical |
| 71610-824-80 | 71610082480 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-824-80) | 2024-04-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gemfibrozil Tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2024-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |