Rosuvastatin Calcium
- Product NDC
- 82804-176
- 11-digit product format
- 828040176
- Labeler code
- 82804
- Product ID
- 82804-176_dc7bfc79-9ee3-46e7-b55d-aba88648ad3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- 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 |
|---|
| 82804-176-90 | 82804017690 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-176-90) | 2024-12-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin Calcium | Proficient Rx LP | 2024-12-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |