Rosuvastatin calcium
- Product NDC
- 71610-215
- 11-digit product format
- 716100215
- Labeler code
- 71610
- Product ID
- 71610-215_8829f5bc-538d-4ad6-ad8b-04e28da01924
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA206434
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 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 |
|---|
| 71610-215-45 | 71610021545 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-215-45) | 2018-12-31 | No | No | Historical |
| 71610-215-60 | 71610021560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-215-60) | 2018-12-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin calcium | Aphena Pharma Solutions - Tennessee, LLC | 2019-01-09 | HUMAN PRESCRIPTION DRUG LABEL | 1 |