Gemfibrozil
- Product NDC
- 60687-224
- 11-digit product format
- 606870224
- Labeler code
- 60687
- Product ID
- 60687-224_42ca24f3-2750-b48c-e063-6394a90ac722
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-07-07
- 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 |
|---|
| 60687-224-01 | Gemfibrozil | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 9 |
| 60687-224-11 | Gemfibrozil | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-224 | GEMFIBROZIL TABLET [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240316_4e9e08da-9700-4934-a2b1-4f64c70ea8a2.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 |
|---|
| 60687-224-01 | 60687022401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-224-01) / 1 TABLET in 1 BLISTER PACK (60687-224-11) | 100 blister pack | 2016-07-07 | 0000-00-00 | No | No | Current |
| 60687-224-11 | 60687022411 | 1 in 1 BLISTER PACK | | | | | | Historical |