GEMFIBROZIL
- Product NDC
- 71335-1996
- 11-digit product format
- 713351996
- Labeler code
- 71335
- Product ID
- 71335-1996_bd8a6d6d-ec28-4539-a23b-980e100ac42c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA214603
- Marketing category
- ANDA
- Marketing start
- 2021-01-20
- 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 |
|---|
| 71335-1996 | GEMFIBROZIL TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 5 package rows | 20240828_fe98f68c-7182-4a88-93a5-cbdbb37fb8c2.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 |
|---|
| 71335-1996-1 | 71335199601 | 60 TABLET in 1 BOTTLE (71335-1996-1) | 60 tablet | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-1996-2 | 71335199602 | 30 TABLET in 1 BOTTLE (71335-1996-2) | 30 tablet | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-1996-3 | 71335199603 | 100 TABLET in 1 BOTTLE (71335-1996-3) | 100 tablet | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-1996-4 | 71335199604 | 90 TABLET in 1 BOTTLE (71335-1996-4) | 90 tablet | 2022-02-10 | 0000-00-00 | No | No | Current |
| 71335-1996-5 | 71335199605 | 180 TABLET in 1 BOTTLE (71335-1996-5) | 180 tablet | 2022-02-10 | 0000-00-00 | No | No | Current |