GEMFIBROZIL
- Product NDC
- 70518-4305
- 11-digit product format
- 705184305
- Labeler code
- 70518
- Product ID
- 70518-4305_402d85bd-9a53-95e2-e063-6394a90a1473
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214603
- Marketing category
- ANDA
- Marketing start
- 2025-03-09
- 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 |
|---|
| 70518-4305-0 | GEMFIBROZIL | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4305 | GEMFIBROZIL TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250311_42e40524-57e9-4fee-993f-be0fda14936b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4305-0 | 70518430500 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-4305-0) | 180 tablet | 2025-03-09 | No | No | Historical |