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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemfibrozil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 310459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2025-1 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 103 |
| 71335-2025-2 | Gemfibrozil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 103 |
| 71335-2025-3 | Gemfibrozil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 103 |
| 71335-2025-4 | Gemfibrozil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 103 |
| 71335-2025-5 | Gemfibrozil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2025 | GEMFIBROZIL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 5 package rows | 20240726_e3ef1638-4c2b-4f74-af31-52c081619963.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-2025-1 | 71335202501 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2025-1) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 71335-2025-2 | 71335202502 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2025-2) | 2022-01-03 | 0000-00-00 | No | No | Current |
| 71335-2025-3 | 71335202503 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2025-3) | 2024-07-15 | 0000-00-00 | No | No | Current |
| 71335-2025-4 | 71335202504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2025-4) | 2022-05-17 | 0000-00-00 | No | No | Current |
| 71335-2025-5 | 71335202505 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2025-5) | 2022-01-26 | 0000-00-00 | No | No | Current |