GEMFIBROZIL
- Product NDC
- 71335-0051
- 11-digit product format
- 713350051
- Labeler code
- 71335
- Product ID
- 71335-0051_cc153611-a05f-4d96-8132-1b7da12f24fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMFIBROZIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078012
- Marketing category
- ANDA
- Marketing start
- 2017-03-23
- 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 |
|---|
| 71335-0051-1 | GEMFIBROZIL | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 71335-0051-2 | GEMFIBROZIL | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 71335-0051-3 | GEMFIBROZIL | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 71335-0051-4 | GEMFIBROZIL | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 71335-0051-5 | GEMFIBROZIL | 180 in 1 BOTTLE | TABLET | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0051 | GEMFIBROZIL TABLET [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240828_2cb2de4d-8261-46d8-ae63-c572fdc887d4.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 |
|---|
| 71335-0051-1 | 71335005101 | 60 TABLET in 1 BOTTLE (71335-0051-1) | 60 tablet | 2017-10-03 | 0000-00-00 | No | No | Current |
| 71335-0051-2 | 71335005102 | 30 TABLET in 1 BOTTLE (71335-0051-2) | 30 tablet | 2017-10-03 | 0000-00-00 | No | No | Current |
| 71335-0051-3 | 71335005103 | 100 TABLET in 1 BOTTLE (71335-0051-3) | 100 tablet | 2017-10-03 | 0000-00-00 | No | No | Current |
| 71335-0051-4 | 71335005104 | 90 TABLET in 1 BOTTLE (71335-0051-4) | 90 tablet | 2017-10-03 | 0000-00-00 | No | No | Current |
| 71335-0051-5 | 71335005105 | 180 TABLET in 1 BOTTLE (71335-0051-5) | 180 tablet | 2017-10-03 | 0000-00-00 | No | No | Current |