Gemfibrozil
- Product NDC
- 68382-553
- 11-digit product format
- 683820553
- Labeler code
- 68382
- Product ID
- 68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA204189
- Marketing category
- ANDA
- Marketing start
- 2019-01-15
- 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 |
|---|
| 68382-553 | GEMFIBROZIL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, Legacy NDC, 8 package rows | 20241109_556945e8-4100-4538-bcba-af5b2f13a7e8.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 |
|---|
| 68382-553-01 | 68382055301 | 100 TABLET in 1 BOTTLE (68382-553-01) | 100 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-05 | 68382055305 | 500 TABLET in 1 BOTTLE (68382-553-05) | 500 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-06 | 68382055306 | 30 TABLET in 1 BOTTLE (68382-553-06) | 30 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-10 | 68382055310 | 1000 TABLET in 1 BOTTLE (68382-553-10) | 1000 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-14 | 68382055314 | 60 TABLET in 1 BOTTLE (68382-553-14) | 60 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-16 | 68382055316 | 90 TABLET in 1 BOTTLE (68382-553-16) | 90 tablet | 2019-01-15 | 0000-00-00 | No | No | Current |
| 68382-553-30 | 68382055330 | 10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2019-01-15 | 0000-00-00 | No | No | Current |