Rosuvastatin Calcium
- Product NDC
- 72603-366
- 11-digit product format
- 726030366
- Labeler code
- 72603
- Product ID
- 72603-366_4687569b-7762-fb06-e063-6294a90aadc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx, LLC
- Application
- ANDA207626
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 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 |
|---|
| 72603-366-01 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 72603-366-02 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 72603-366-03 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET | 1000 | | 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 |
|---|
| 72603-366-01 | 72603036601 | 90 TABLET in 1 BOTTLE (72603-366-01) | 90 tablet | 2025-12-15 | No | No | Current |
| 72603-366-02 | 72603036602 | 500 TABLET in 1 BOTTLE (72603-366-02) | 500 tablet | 2025-12-15 | No | No | Current |
| 72603-366-03 | 72603036603 | 1000 TABLET in 1 BOTTLE (72603-366-03) | 1000 tablet | 2025-12-15 | No | No | Current |