Gemfibrozil
- Product NDC
- 50090-7234
- 11-digit product format
- 500907234
- Labeler code
- 50090
- Product ID
- 50090-7234_ce1cb74e-4218-4fdb-a84b-bd5918d2f120
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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 |
|---|
| 50090-7234-0 | Gemfibrozil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7234 | GEMFIBROZIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20240830_16d0326a-a55b-448b-be24-a16182aaef5a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7234-0 | 50090723400 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7234-0) | 2024-08-26 | No | No | Historical |