Rosuvastatin
- Product NDC
- 70518-3519
- 11-digit product format
- 705183519
- Labeler code
- 70518
- Product ID
- 70518-3519_ed9a0f33-dd3a-1cb1-e053-2995a90a1a47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206434
- Marketing category
- ANDA
- Marketing start
- 2022-09-14
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3519-0 | 70518351900 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3519-0) | 2022-09-14 | 0000-00-00 | No | No | Current |