Rosuvastatin
- Product NDC
- 68071-3847
- 11-digit product format
- 680713847
- Labeler code
- 68071
- Product ID
- 68071-3847_351ef166-88b1-3f45-e063-6394a90a00d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- Active strength
- 20 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 |
|---|
| 413KH5ZJ73 | ROSUVASTATIN | 287714-41-4 | ROSUVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3847-2 | 68071384702 | 120 TABLET, FILM COATED in 1 BOTTLE (68071-3847-2) | 2025-05-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin | NuCare Pharmaceuticals, Inc. | 2025-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |