Rosuvastatin Calcium
- Product NDC
- 68788-4047
- 11-digit product format
- 687884047
- Labeler code
- 68788
- Product ID
- 68788-4047_1eb971e3-de67-46ae-a8ef-8a7d2805cfdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207626
- Marketing category
- ANDA
- Marketing start
- 2025-10-28
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4047-2 | 68788404702 | 20 TABLET in 1 BOTTLE (68788-4047-2) | 20 tablet | 2025-10-28 | No | No | Historical |
| 68788-4047-3 | 68788404703 | 30 TABLET in 1 BOTTLE (68788-4047-3) | 30 tablet | 2025-10-28 | No | No | Historical |
| 68788-4047-6 | 68788404706 | 60 TABLET in 1 BOTTLE (68788-4047-6) | 60 tablet | 2025-10-28 | No | No | Historical |
| 68788-4047-9 | 68788404709 | 90 TABLET in 1 BOTTLE (68788-4047-9) | 90 tablet | 2025-10-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | Preferred Pharmaceuticals Inc. | 2025-10-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |