Rosuvastatin
- Product NDC
- 71610-922
- 11-digit product format
- 716100922
- Labeler code
- 71610
- Product ID
- 71610-922_398281a7-68c9-e4d7-e063-6394a90a8ae9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- Active strength
- 20 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-922-45 | Rosuvastatin | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-922-45 | 71610092245 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-922-45) | 2025-07-08 | No | No | Current |