Rosuvastatin
- Product NDC
- 51407-850
- 11-digit product format
- 514070850
- Labeler code
- 51407
- Product ID
- 51407-850_32d8af6b-ed18-ad03-e063-6394a90a078d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, 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 |
|---|
| 51407-850-10 | 51407085010 | 1000 TABLET, FILM COATED in 1 BOTTLE (51407-850-10) | 2023-12-18 | No | No | Historical |
| 51407-850-90 | 51407085090 | 90 TABLET, FILM COATED in 1 BOTTLE (51407-850-90) | 2023-12-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin | Golden State Medical Supply, Inc. | 2025-04-15 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| Rosuvastatin | Aphena Pharma Solutions - Tennessee, LLC | 2024-03-06 | HUMAN PRESCRIPTION DRUG LABEL | 3 |