Gemfibrozil
- Product NDC
- 71335-2025
- 11-digit product format
- 713352025
- Labeler code
- 71335
- Product ID
- 71335-2025_65788163-66b9-44fb-a267-a313c4329020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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
openFDA Listing Details
- Product ID
- 71335-2025_65788163-66b9-44fb-a267-a313c4329020
- SPL ID
- 65788163-66b9-44fb-a267-a313c4329020
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Gemfibrozil
- Generic name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2015-09-16
- Marketing category
- ANDA
- Application number
- ANDA202726
- Pharmacologic classes
- PPAR alpha [CS]; Peroxisome Proliferator Receptor alpha Agonist [EPC]; Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 310459 |
| Spl Set Id | e3ef1638-4c2b-4f74-af31-52c081619963 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2025-1 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2025-1) | 2022-04-29 | No |
| 71335-2025-2 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2025-2) | 2022-01-03 | No |
| 71335-2025-3 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2025-3) | 2024-07-15 | No |
| 71335-2025-4 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2025-4) | 2022-05-17 | No |
| 71335-2025-5 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2025-5) | 2022-01-26 | No |
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 |
|---|
| 71335-2025-1 | 71335202501 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2025-1) | 2022-04-29 | No | No | Historical |
| 71335-2025-2 | 71335202502 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2025-2) | 2022-01-03 | No | No | Historical |
| 71335-2025-3 | 71335202503 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2025-3) | 2024-07-15 | No | No | Historical |
| 71335-2025-4 | 71335202504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2025-4) | 2022-05-17 | No | No | Historical |
| 71335-2025-5 | 71335202505 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2025-5) | 2022-01-26 | No | No | Historical |