Gemfibrozil
- Product NDC
- 67046-0233
- 11-digit product format
- 670460233
- Labeler code
- 67046
- Product ID
- 67046-0233_509e7c9a-6262-a1df-e063-6394a90aaeac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2026-04-29
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemfibrozil
- Listing expiration
- 2027-12-31
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 |
|---|
| 67046-0233-3 | Gemfibrozil | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-0233-3 | 67046023303 | 30 TABLET in 1 BLISTER PACK (67046-0233-3) | 30 tablet | 2026-04-29 | No | No | Current |