GEMFIBROZIL
- Product NDC
- 43063-921
- 11-digit product format
- 430630921
- Labeler code
- 43063
- Product ID
- 43063-921_e6da3695-c869-ebac-e053-2a95a90a7df4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMFIBROZIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078012
- Marketing category
- ANDA
- Marketing start
- 2017-03-23
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-921 | GEMFIBROZIL TABLET [PD-RX PHARMACEUTICALS, INC.] | 12 | Legacy NDC | 20240704_fd7c7a13-4d2a-4b98-8e1d-a1a99c3657e9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-921-60 | 43063092160 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-921-60) | 60 tablet | 2018-12-26 | 0000-00-00 | No | No | Current |