Rosuvastatin
- Product NDC
- 68788-4057
- 11-digit product format
- 687884057
- Labeler code
- 68788
- Product ID
- 68788-4057_26d14bab-ee7c-49fe-9fb0-8426a589b599
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2025-11-24
- Substance
- ROSUVASTATIN
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4057-2 | Rosuvastatin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 68788-4057-3 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 68788-4057-6 | Rosuvastatin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 68788-4057-9 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4057-2 | 68788405702 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-4057-2) | 2025-11-24 | No | No | Historical |
| 68788-4057-3 | 68788405703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4057-3) | 2025-11-24 | No | No | Historical |
| 68788-4057-6 | 68788405706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4057-6) | 2025-11-24 | No | No | Historical |
| 68788-4057-9 | 68788405709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4057-9) | 2025-11-24 | No | No | Historical |