Gemfibrozil
- Product NDC
- 71610-107
- 11-digit product format
- 716100107
- Labeler code
- 71610
- Product ID
- 71610-107_54b54e0a-1488-4e0e-bffe-0980faf6f25b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2006-10-20
- 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 |
|---|
| 71610-107-53 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 71610-107-60 | Gemfibrozil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 71610-107-80 | Gemfibrozil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-107 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20180829_30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-107-53 | 71610010753 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-107-53) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 71610-107-60 | 71610010760 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-107-60) | 2018-07-31 | 0000-00-00 | No | No | Current |
| 71610-107-80 | 71610010780 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-107-80) | 2018-07-31 | 0000-00-00 | No | No | Current |