Gemfibrozil
- Product NDC
- 70771-1431
- 11-digit product format
- 707711431
- Labeler code
- 70771
- Product ID
- 70771-1431_2f3cb828-6ff1-428d-99c7-edb835d25d10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA204189
- Marketing category
- ANDA
- Marketing start
- 2020-02-21
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1431 | GEMFIBROZIL TABLET [ZYDUS LIFESCIENCES LIMITED] | 4 | Current NDC, Legacy NDC, 8 package rows | 20231216_e6bc1a4f-2a4f-4fdf-8084-488ec8b8b7ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1431-0 | 70771143100 | 1000 TABLET in 1 BOTTLE (70771-1431-0) | 1000 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-1 | 70771143101 | 100 TABLET in 1 BOTTLE (70771-1431-1) | 100 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-3 | 70771143103 | 30 TABLET in 1 BOTTLE (70771-1431-3) | 30 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-4 | 70771143104 | 10 BLISTER PACK in 1 CARTON (70771-1431-4) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-5 | 70771143105 | 500 TABLET in 1 BOTTLE (70771-1431-5) | 500 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-6 | 70771143106 | 60 TABLET in 1 BOTTLE (70771-1431-6) | 60 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 70771-1431-9 | 70771143109 | 90 TABLET in 1 BOTTLE (70771-1431-9) | 90 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |