Rosuvastatin Calcium
- Product NDC
- 81288-755
- 11-digit product format
- 812880755
- Labeler code
- 81288
- Product ID
- 81288-755_e48eb21b-bb32-4230-b985-d9dcb18960b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- EMC PHARMA, LLC
- Application
- ANDA207375
- Marketing category
- ANDA
- Marketing start
- 2022-07-28
- 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 |
|---|
| 81288-755-90 | 81288075590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81288-755-90) | 2022-07-28 | 0000-00-00 | No | No | Current |