Rosuvastatin calcium
- Product NDC
- 71610-133
- 11-digit product format
- 716100133
- Labeler code
- 71610
- Product ID
- 71610-133_5872733a-20c5-48d1-8e27-79d914131f7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA207752
- Marketing category
- ANDA
- Marketing start
- 2016-10-31
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 |
|---|
| 71610-133-15 | 71610013315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-15) | 2018-08-27 | No | No | Historical |
| 71610-133-30 | 71610013330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-30) | 2018-09-04 | No | No | Historical |
| 71610-133-45 | 71610013345 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-133-45) | 2018-08-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin calcium | Aphena Pharma Solutions - Tennessee, LLC | 2018-09-12 | HUMAN PRESCRIPTION DRUG LABEL | 1 |