Rosuvastatin Calcium
- Product NDC
- 68788-4078
- 11-digit product format
- 687884078
- Labeler code
- 68788
- Product ID
- 68788-4078_1f61e43b-0b9f-48a3-bd8e-94e66534e271
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207626
- Marketing category
- ANDA
- Marketing start
- 2026-02-17
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859424 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4078-3 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 68788-4078-6 | Rosuvastatin Calcium | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 68788-4078-9 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4078-3 | 68788407803 | 30 TABLET in 1 BOTTLE (68788-4078-3) | 30 tablet | 2026-02-17 | No | No | Historical |
| 68788-4078-6 | 68788407806 | 60 TABLET in 1 BOTTLE (68788-4078-6) | 60 tablet | 2026-02-17 | No | No | Historical |
| 68788-4078-9 | 68788407809 | 90 TABLET in 1 BOTTLE (68788-4078-9) | 90 tablet | 2026-02-17 | No | No | Historical |