Gemfibrozil
- Product NDC
- 65862-624
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202726
- Marketing category
- ANDA
- Substance
- GEMFIBROZIL
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 65862-624-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-624-05) | 2015-09-16 | No | Historical | |
| 65862-624-60 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-624-60) | 2015-09-16 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| Gemfibrozil Tablets, USP Rx only | Aurobindo Pharma Limited | 2024-05-15 | Human Prescription Drug Label | 9 |
| Gemfibrozil Tablets, USP Rx only | NCS HealthCare of KY, LLC dba Vangard Labs | 2022-08-29 | HUMAN PRESCRIPTION DRUG LABEL | 4 |