Rosuvastatin calcium
- Product NDC
- 42708-191
- 11-digit product format
- 427080191
- Labeler code
- 42708
- Product ID
- 42708-191_519efcd6-a50c-1343-e063-6394a90afc78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- QPharma, Inc.
- Application
- ANDA079172
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-191-30 | Rosuvastatin calcium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42708-191-30 | 42708019130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-191-30) | 2025-10-17 | Yes | No | Historical |