Gemfibrozil
- Product NDC
- 71335-0899
- 11-digit product format
- 713350899
- Labeler code
- 71335
- Product ID
- 71335-0899_4532f5fd-0396-481e-b827-fbf12e025231
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0899-1 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 71335-0899-2 | Gemfibrozil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 71335-0899-3 | Gemfibrozil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 71335-0899-4 | Gemfibrozil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 71335-0899-5 | Gemfibrozil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0899 | GEMFIBROZIL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 4 | Legacy NDC, 5 package rows | 20220202_4532f5fd-0396-481e-b827-fbf12e025231.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-0899-1 | 71335089901 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0899-1) | 2018-07-17 | 0000-00-00 | No | No | Current |
| 71335-0899-2 | 71335089902 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0899-2) | 2018-07-17 | 0000-00-00 | No | No | Current |
| 71335-0899-3 | 71335089903 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0899-3) | 2018-07-17 | 0000-00-00 | No | No | Current |
| 71335-0899-4 | 71335089904 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0899-4) | 2018-07-17 | 0000-00-00 | No | No | Current |
| 71335-0899-5 | 71335089905 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0899-5) | 2018-07-17 | 0000-00-00 | No | No | Current |