Rosuvastatin calcium
- Product NDC
- 0781-5400
- 11-digit product format
- 007815400
- Labeler code
- 0781
- Product ID
- 0781-5400_04d6d11e-f5fa-4dc8-8af7-a4983ddcb8de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA079171
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- 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
- 2021-12-31
- 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 |
|---|
| 0781-5400-92 | 00781540092 | 90 TABLET, FILM COATED in 1 BOTTLE (0781-5400-92) | 2016-07-19 | 0000-00-00 | No | No | Current |