Gemfibrozil
- Product NDC
- 51655-143
- 11-digit product format
- 516550143
- Labeler code
- 51655
- Product ID
- 51655-143_48c3ec58-2075-5cc3-e063-6394a90aaffa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2017-08-14
- 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 |
|---|
| 51655-143-25 | Gemfibrozil | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 4 |
| 51655-143-26 | Gemfibrozil | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
| 51655-143-52 | Gemfibrozil | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
| 51655-143-83 | Gemfibrozil | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-143 | GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230324_a95264ab-eb86-7699-e053-2995a90a3d1f.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 |
|---|
| 51655-143-25 | 51655014325 | 60 TABLET in 1 BOTTLE, PLASTIC (51655-143-25) | 60 tablet | 2022-12-06 | | No | No | Historical |
| 51655-143-26 | 51655014326 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-143-26) | 90 tablet | 2017-08-14 | 0000-00-00 | No | No | Current |
| 51655-143-52 | 51655014352 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-143-52) | 30 tablet | 2017-11-13 | 0000-00-00 | No | No | Current |
| 51655-143-83 | 51655014383 | 180 TABLET in 1 BOTTLE, PLASTIC (51655-143-83) | 180 tablet | 2017-08-14 | 0000-00-00 | No | No | Current |