Gemfibrozil
- Product NDC
- 53217-251
- 11-digit product format
- 532170251
- Labeler code
- 53217
- Product ID
- 53217-251_5c29f1a0-da1b-43cd-9409-218c79d2c17d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-07-08
- Marketing end
- 0000-00-00
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-251-30 | Gemfibrozil | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-251-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-251-90 | Gemfibrozil | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 53217-251-99 | Gemfibrozil | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-251 | GEMFIBROZIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20161206_2e46fee5-d646-43a2-8737-8b09094043e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-251-30 | 53217025130 | 30 in 1 BOTTLE | Historical |
| 53217-251-60 | 53217025160 | 60 in 1 BOTTLE | Historical |
| 53217-251-90 | 53217025190 | 90 in 1 BOTTLE | Historical |
| 53217-251-99 | 53217025199 | 180 in 1 BOTTLE | Historical |