Gemfibrozil
- Product NDC
- 71335-1902
- 11-digit product format
- 713351902
- Labeler code
- 71335
- Product ID
- 71335-1902_be2e589c-9e89-462a-844a-d3617a68a8d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203266
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- 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 |
|---|
| 71335-1902 | GEMFIBROZIL TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 5 package rows | 20231025_fe91d458-1877-4c2e-aa15-efd802e6741f.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 |
|---|
| 71335-1902-1 | 71335190201 | 60 TABLET in 1 BOTTLE (71335-1902-1) | 60 tablet | 2021-07-13 | 0000-00-00 | No | No | Current |
| 71335-1902-2 | 71335190202 | 30 TABLET in 1 BOTTLE (71335-1902-2) | 30 tablet | 2021-08-03 | 0000-00-00 | No | No | Current |
| 71335-1902-3 | 71335190203 | 100 TABLET in 1 BOTTLE (71335-1902-3) | 100 tablet | 2022-03-10 | 0000-00-00 | No | No | Current |
| 71335-1902-4 | 71335190204 | 90 TABLET in 1 BOTTLE (71335-1902-4) | 90 tablet | 2022-03-10 | 0000-00-00 | No | No | Current |
| 71335-1902-5 | 71335190205 | 180 TABLET in 1 BOTTLE (71335-1902-5) | 180 tablet | 2021-09-13 | 0000-00-00 | No | No | Current |