Rosuvastatin Calcium
- Product NDC
- 60290-044
- 11-digit product format
- 602900044
- Labeler code
- 60290
- Product ID
- 60290-044_4b2de301-734e-64eb-e063-6394a90a5b91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Umedica Laboratories USA Inc.
- Application
- ANDA207626
- Marketing category
- ANDA
- Marketing start
- 2025-11-30
- 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 Calcium
- 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 |
|---|
| 60290-044-01 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 60290-044-02 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET | 90 | | 13 |
| 60290-044-03 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 60290-044-04 | Rosuvastatin Calcium | 100 in 1 BLISTER PACK | TABLET | 100 | | 13 |
| 60290-044-05 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET | 1000 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60290-044 | ROSUVASTATIN CALCIUM TABLET [UMEDICA LABORATORIES PRIVATE LIMITED] | 7 | Current NDC, 5 package rows | 20250313_989dffcf-0254-439d-9f3f-3b0e9d32de0a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60290-044-01 | 60290004401 | 30 TABLET in 1 BOTTLE (60290-044-01) | 30 tablet | 2026-02-15 | No | No | Current |
| 60290-044-02 | 60290004402 | 90 TABLET in 1 BOTTLE (60290-044-02) | 90 tablet | 2025-11-30 | No | No | Current |
| 60290-044-03 | 60290004403 | 500 TABLET in 1 BOTTLE (60290-044-03) | 500 tablet | 2025-11-30 | No | No | Current |
| 60290-044-04 | 60290004404 | 100 TABLET in 1 BLISTER PACK (60290-044-04) | 100 tablet | 2026-02-15 | No | No | Current |
| 60290-044-05 | 60290004405 | 1000 TABLET in 1 BOTTLE (60290-044-05) | 1000 tablet | 2025-11-30 | No | No | Current |