Rosuvastatin Calcium
- Product NDC
- 68071-5225
- 11-digit product format
- 680715225
- Labeler code
- 68071
- Product ID
- 68071-5225_1b590b21-1fb2-172c-e063-6394a90ae8c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- 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 |
|---|
| 68071-5225-9 | 68071522509 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-5225-9) | 2020-03-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | 2024-06-20 | HUMAN PRESCRIPTION DRUG LABEL | 3 |