Rosuvastatin
- Product NDC
- 68788-8649
- 11-digit product format
- 687888649
- Labeler code
- 68788
- Product ID
- 68788-8649_fea7682a-bb25-4976-8603-e54fbc0f1e50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2024-05-03
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 83MVU38M7Q | ROSUVASTATIN CALCIUM | 147098-20-2 | ROSUVASTATIN CALCIUM |
| 413KH5ZJ73 | ROSUVASTATIN | 287714-41-4 | Rosuvastatin |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8649-2 | 68788864902 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8649-2) | 2024-05-03 | No | No | Historical |
| 68788-8649-3 | 68788864903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8649-3) | 2024-05-03 | No | No | Historical |
| 68788-8649-6 | 68788864906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8649-6) | 2024-05-03 | No | No | Historical |
| 68788-8649-9 | 68788864909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8649-9) | 2024-05-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin | Preferred Pharmaceuticals Inc. | 2025-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 2 |