Rosuvastatin
- Product NDC
- 70518-4303
- 11-digit product format
- 705184303
- Labeler code
- 70518
- Product ID
- 70518-4303_39e35072-2886-20fc-e063-6394a90aa36e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2025-03-04
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 413KH5ZJ73 | ROSUVASTATIN | 287714-41-4 | ROSUVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4303-0 | 70518430300 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-0) | 2025-03-04 | No | No | Historical |
| 70518-4303-1 | 70518430301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-1) | 2025-03-28 | No | No | Historical |
| 70518-4303-2 | 70518430302 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4303-2) | 2025-04-25 | No | No | Historical |
| 70518-4303-3 | 70518430303 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4303-3) | 2025-07-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin | REMEDYREPACK INC. | 2025-07-14 | HUMAN PRESCRIPTION DRUG LABEL | 5 |