Rosuvastatin Calcium
- Product NDC
- 0615-8534
- 11-digit product format
- 006158534
- Labeler code
- 0615
- Product ID
- 0615-8534_9feb1012-a261-4a00-a854-26cff1a6f517
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Substance
- ROSUVASTATIN CALCIUM
- 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 |
|---|
| 83MVU38M7Q | ROSUVASTATIN CALCIUM | 147098-20-2 | ROSUVASTATIN CALCIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8534-05 | 00615853405 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8534-05) | 2024-09-13 | No | No | Historical |
| 0615-8534-39 | 00615853439 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8534-39) | 2024-09-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-09-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |