Rosuvastatin Calcium
- Product NDC
- 57237-171
- 11-digit product format
- 572370171
- Labeler code
- 57237
- Product ID
- 57237-171_20865c19-8939-458b-b3db-d38f3fb00bed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 |
|---|---|
| ROSUVASTATIN CALCIUM | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c8f25656-847a-4de8-96a7-06bf98d83c2b | Product name | 1 | 20210916 |
| b6a872b4-e31a-fff0-6f62-fd0253265e2f | Product name | 9 | 20190618 |
| 5a2818e5-ef92-49b1-bc6c-9fe2427d21d5 | Product name | 1 | 20190429 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-171-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 15 | |
| 57237-171-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 15 | |
| 57237-171-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 15 | |
| 57237-171-99 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-171-05 | EA - Each | 57237-171 | 100c17ba-5884-4736-a05a-0919e4f90c4b | 1 | 2016-11-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 85ed9283-4e16-41bf-95ed-01b62640fd2c | 37 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 5c992d3d-d754-48b6-a267-1451208352ed | 15 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | a9478b12-89d2-42a4-a310-707a87ef43d7 | 5 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | a9478b12-89d2-42a4-a310-707a87ef43d7 | 5 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57237-171-05 | 57237017105 | 500 TABLET, FILM COATED in 1 BOTTLE (57237-171-05) | 2016-07-19 | 0000-00-00 | No | No | Current |
| 57237-171-30 | 57237017130 | 30 TABLET, FILM COATED in 1 BOTTLE (57237-171-30) | 2016-07-19 | 0000-00-00 | No | No | Current |
| 57237-171-90 | 57237017190 | 90 TABLET, FILM COATED in 1 BOTTLE (57237-171-90) | 2016-07-19 | 0000-00-00 | No | No | Current |
| 57237-171-99 | 57237017199 | 1000 TABLET, FILM COATED in 1 BOTTLE (57237-171-99) | 2016-07-19 | 0000-00-00 | No | No | Current |