Rosuvastatin
- Product NDC
- 68788-7971
- 11-digit product format
- 687887971
- Labeler code
- 68788
- Product ID
- 68788-7971_7014a4df-8c38-4de7-87a3-8d35fe26fcc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206434
- Marketing category
- ANDA
- Marketing start
- 2021-07-21
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7971-3 | 68788797103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7971-3) | 2021-07-21 | 0000-00-00 | No | No | Current |
| 68788-7971-6 | 68788797106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7971-6) | 2021-07-21 | 0000-00-00 | No | No | Current |
| 68788-7971-9 | 68788797109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7971-9) | 2021-07-21 | 0000-00-00 | No | No | Current |