Gemfibrozil
- Product NDC
- 53002-1068
- 11-digit product format
- 530021068
- Labeler code
- 53002
- Product ID
- 53002-1068_f2cdc8de-6eb7-47ec-a4af-eedd35f01aaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-10-13
- 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
- 2021-12-31
- 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 |
|---|
| 53002-1068-0 | Gemfibrozil | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1068 | GEMFIBROZIL TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_07e298e2-c324-4524-a4f6-4d1162d78376.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 |
|---|
| 53002-1068-0 | 53002106800 | 100 TABLET in 1 BOTTLE (53002-1068-0) | 100 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |