Rosuvastatin Calcium
- Product NDC
- 50090-5468
- 11-digit product format
- 500905468
- Labeler code
- 50090
- Product ID
- 50090-5468_9b84c57f-716c-4263-a62a-67538fa97859
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA206465
- Marketing category
- ANDA
- Marketing start
- 2017-03-21
- 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
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-5468-0 | 50090546800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5468-0) | 2021-02-16 | No | No | Historical |
| 50090-5468-1 | 50090546801 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5468-1) | 2021-02-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | A-S Medication Solutions | 2023-02-06 | Human Prescription Drug Label | 3 |