Rosuvastatin
- Product NDC
- 70518-1219
- 11-digit product format
- 705181219
- Labeler code
- 70518
- Product ID
- 70518-1219_e3368bac-d820-3d52-e053-2a95a90a6dd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2018-05-18
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1219-0 | 70518121900 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1219-0) | | 2018-05-18 | 0000-00-00 | No | No | Current |
| 70518-1219-2 | 70518121902 | 30 POUCH in 1 BOX (70518-1219-2) > 1 TABLET, FILM COATED in 1 POUCH (70518-1219-3) | 30 pouch | 2021-01-14 | 0000-00-00 | No | No | Current |