Gemfibrozil
- Product NDC
- 71205-169
- 11-digit product format
- 712050169
- Labeler code
- 71205
- Product ID
- 71205-169_73ae4ea5-2353-487f-a6f1-04d0077fc551
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-169 | GEMFIBROZIL TABLET, FILM COATED [PROFICIENT RX LP] | 2 | Legacy NDC | 20191122_e0cd766f-a1dd-440b-bfde-e2fb09f84a0e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-169-30 | 71205016930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-169-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 71205-169-60 | 71205016960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-169-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 71205-169-90 | 71205016990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-169-90) | 2018-12-01 | 0000-00-00 | No | No | Current |