Rosuvastatin
- Product NDC
- 11788-131
- 11-digit product format
- 117880131
- Labeler code
- 11788
- Product ID
- 11788-131_42b21540-4538-4c56-adb7-b9cfe8b2b2d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA206513
- Marketing category
- ANDA
- Marketing start
- 2026-01-30
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11788-131-05 | Rosuvastatin | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 1 |
| 11788-131-10 | Rosuvastatin | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 1 |
| 11788-131-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 11788-131-05 | 11788013105 | 500 TABLET, COATED in 1 BOTTLE (11788-131-05) | 2026-01-30 | No | No | Historical |
| 11788-131-10 | 11788013110 | 1000 TABLET, COATED in 1 BOTTLE (11788-131-10) | 2026-01-30 | No | No | Historical |
| 11788-131-90 | 11788013190 | 90 TABLET, COATED in 1 BOTTLE (11788-131-90) | 2026-01-30 | No | No | Historical |