Rosuvastatin
- Product NDC
- 55154-0159
- 11-digit product format
- 551540159
- Labeler code
- 55154
- Product ID
- 55154-0159_9baad60e-b35a-46f7-905f-f731c056961c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2025-10-16
- 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
- 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 |
|---|
| 55154-0159-0 | Rosuvastatin | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
| 55154-0159-0 | Rosuvastatin | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-0159-0 | 55154015900 | 10 BLISTER PACK in 1 BAG (55154-0159-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-10-16 | No | No | Historical |