GEMFIBROZIL
- Product NDC
- 71610-601
- 11-digit product format
- 716100601
- Labeler code
- 71610
- Product ID
- 71610-601_8cfd64d4-38e2-4c2c-97b0-9284da5fe6da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-601-53 | GEMFIBROZIL | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71610-601-60 | GEMFIBROZIL | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-601 | GEMFIBROZIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211104_7379a1c1-d34f-4eb8-acb8-c5cbaea0f017.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 |
|---|
| 71610-601-53 | 71610060153 | 60 TABLET in 1 BOTTLE (71610-601-53) | 60 tablet | 2021-10-19 | 0000-00-00 | No | No | Current |
| 71610-601-60 | 71610060160 | 90 TABLET in 1 BOTTLE (71610-601-60) | 90 tablet | 2021-10-06 | 0000-00-00 | No | No | Current |