Prescription drug · ANDA
Rosuvastatin Calcium NDC 50090-6522
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6522-0 | 50090652200 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6522-0)Marketed from Jun 13, 2023 | |
| 50090-6522-1 | 50090652201 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6522-1)Marketed from Jun 13, 2023 | |
| 50090-6522-2 | 50090652202 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6522-2)Marketed from Jun 13, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079170
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6522_d28f3d49-51dd-4100-8f27-ef80c96420eaSPL ID d28f3d49-51dd-4100-8f27-ef80c96420eaSPL set ID d147d4b2-5c2a-44d2-abb6-e77715f2b0f5RxCUI 859751UNII 83MVU38M7Q
- 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
N450090652200followed by a unit qualifier and the quantityPackage 50090-6522-00. 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 are 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 without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholeste…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079170
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 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8535 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8532 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8533 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8534 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-293 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-296 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-294 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7413 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-295 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7414 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-078 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4710 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3722 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-235 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-245 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7486 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-234 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7487 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-256 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7489 |
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