Rosuvastatin Calcium
- Product NDC
- 47335-584
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA079169
- Marketing category
- ANDA
- Substance
- ROSUVASTATIN CALCIUM
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-584-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-584-18) | 20230623 | | No | Historical |
| 47335-584-81 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-584-81) | 20210301 | | No | Historical |
| 47335-584-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-584-83) | 20230623 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| ef243da2-d388-40e4-a1cb-a5e0688efc49 | These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2024-08-08 | Human Prescription Drug Label | 16 |