Rosuvastatin Calcium
- Product NDC
- 71205-475
- 11-digit product format
- 712050475
- Labeler code
- 71205
- Product ID
- 71205-475_b2f702dc-1c6e-4217-b88a-1cc8a54fbb1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207408
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-475-30 | 71205047530 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-475-30) | 2020-09-22 | No | No | Historical |
| 71205-475-60 | 71205047560 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-475-60) | 2020-09-22 | No | No | Historical |
| 71205-475-90 | 71205047590 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-475-90) | 2020-09-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | Proficient Rx LP | 2022-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |