Gemfibrozil
- Product NDC
- 72578-066
- 11-digit product format
- 725780066
- Labeler code
- 72578
- Product ID
- 72578-066_81e93b62-553c-4553-9f0e-44f06293ae7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA204189
- Marketing category
- ANDA
- Marketing start
- 2020-02-21
- 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 |
|---|
| 72578-066 | GEMFIBROZIL TABLET [VIONA PHARMACEUTICALS INC] | 3 | Current NDC, Legacy NDC, 8 package rows | 20231216_2fc2c8fe-6158-4e4d-9753-dc2be1b10f42.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 |
|---|
| 72578-066-01 | 72578006601 | 100 TABLET in 1 BOTTLE (72578-066-01) | 100 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-05 | 72578006605 | 500 TABLET in 1 BOTTLE (72578-066-05) | 500 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-06 | 72578006606 | 30 TABLET in 1 BOTTLE (72578-066-06) | 30 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-10 | 72578006610 | 1000 TABLET in 1 BOTTLE (72578-066-10) | 1000 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-14 | 72578006614 | 60 TABLET in 1 BOTTLE (72578-066-14) | 60 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-16 | 72578006616 | 90 TABLET in 1 BOTTLE (72578-066-16) | 90 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 72578-066-30 | 72578006630 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 72578-066-77 | 72578006677 | 10 BLISTER PACK in 1 CARTON (72578-066-77) / 10 TABLET in 1 BLISTER PACK (72578-066-30) | 10 blister pack | 2020-02-21 | 0000-00-00 | No | No | Current |