ROSUVASTATIN CALCIUM
- Product NDC
- 43353-352
- 11-digit product format
- 433530352
- Labeler code
- 43353
- Product ID
- 43353-352_6398df0f-8c43-4428-b882-3f5efb53ae00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2017-02-02
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 83MVU38M7Q | ROSUVASTATIN CALCIUM | 147098-20-2 | ROSUVASTATIN CALCIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-352-15 | 43353035215 | 15 TABLET in 1 BOTTLE (43353-352-15) | 15 tablet | 2017-06-01 | 0000-00-00 | No | No | Current |
| 43353-352-18 | 43353035218 | 3000 TABLET in 1 BOTTLE (43353-352-18) | 3000 tablet | 2017-05-04 | 0000-00-00 | No | No | Current |
| 43353-352-19 | 43353035219 | 3060 TABLET in 1 BOTTLE (43353-352-19) | 3060 tablet | 2017-05-26 | 0000-00-00 | No | No | Current |
| 43353-352-45 | 43353035245 | 45 TABLET in 1 BOTTLE (43353-352-45) | 45 tablet | 2017-05-12 | 0000-00-00 | No | No | Current |
| 43353-352-60 | 43353035260 | 90 TABLET in 1 BOTTLE (43353-352-60) | 90 tablet | 2017-05-11 | 0000-00-00 | No | No | Current |