Gemfibrozil
- Product NDC
- 71209-008
- 11-digit product format
- 712090008
- Labeler code
- 71209
- Product ID
- 71209-008_b3071718-e27b-4690-88dd-fc58a4fcbf41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA203266
- Marketing category
- ANDA
- Marketing start
- 2016-06-17
- 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 |
|---|
| 71209-008-03 | Gemfibrozil | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 71209-008-08 | Gemfibrozil | 180 in 1 BOTTLE | TABLET | 180 | | 6 |
| 71209-008-10 | Gemfibrozil | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-008 | GEMFIBROZIL TABLET [CADILA PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20221228_0b50849a-66b6-4e8f-9f45-5425a875d366.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 |
|---|
| 71209-008-03 | 71209000803 | 60 TABLET in 1 BOTTLE (71209-008-03) | 60 tablet | 2018-10-17 | 0000-00-00 | No | No | Current |
| 71209-008-08 | 71209000808 | 180 TABLET in 1 BOTTLE (71209-008-08) | 180 tablet | 2018-10-17 | 0000-00-00 | No | No | Current |
| 71209-008-10 | 71209000810 | 500 TABLET in 1 BOTTLE (71209-008-10) | 500 tablet | 2018-10-17 | 0000-00-00 | No | No | Current |