Prescription drug · ANDA
Rosuvastatin Calcium NDC 60290-044
Rosuvastatin calcium 10 mg/1 · Tablet · Oral · Umedica Laboratories USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60290-044-01 | 60290004401 | 30 TABLET in 1 BOTTLE (60290-044-01)Marketed from Feb 15, 2026 | |
| 60290-044-02 | 60290004402 | 90 TABLET in 1 BOTTLE (60290-044-02)Marketed from Nov 30, 2025 | |
| 60290-044-03 | 60290004403 | 500 TABLET in 1 BOTTLE (60290-044-03)Marketed from Nov 30, 2025 | |
| 60290-044-04 | 60290004404 | 100 TABLET in 1 BLISTER PACK (60290-044-04)Marketed from Feb 15, 2026 | |
| 60290-044-05 | 60290004405 | 1000 TABLET in 1 BOTTLE (60290-044-05)Marketed from Nov 30, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Rosuvastatin Calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207626
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 60290-044_5368ad40-da32-8cfd-e063-6294a90ae598SPL ID 5368ad40-da32-8cfd-e063-6294a90ae598SPL set ID 989dffcf-0254-439d-9f3f-3b0e9d32de0aRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0360290045014, 0360290043010, 0360290046011, 0360290044017
- Pharmacologic class
- HMG-CoA Reductase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460290004401followed by a unit qualifier and the quantityPackage 60290-0044-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Rosuvastatin tablets is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults w…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207626
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8775 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4697 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3623 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7968 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7967 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3668 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7975 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7976 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3172 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-366 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-364 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-365 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-367 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4047 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4078 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-720 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-721 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-722 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-723 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-046 |
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