Rosuvastatin
- Product NDC
- 70518-1601
- 11-digit product format
- 705181601
- Labeler code
- 70518
- Product ID
- 70518-1601_c33f16ea-ac32-ec3a-e053-2995a90a1165
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2018-10-26
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 70518-1601-1 | 70518160101 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1601-1) | 2018-12-04 | 0000-00-00 | No | No | Current |