Prescription drug · ANDA
Rosuvastatin NDC 71610-796
Rosuvastatin 20 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-796-15 | 71610079615 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-796-15)Marketed from Mar 5, 2024 | |
| 71610-796-30 | 71610079630 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-796-30)Marketed from Feb 14, 2024 | |
| 71610-796-45 | 71610079645 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-796-45)Marketed from Feb 14, 2024 | |
| 71610-796-53 | 71610079653 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-796-53)Marketed from Feb 14, 2024 | |
| 71610-796-60 | 71610079660 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-796-60)Marketed from Feb 14, 2024 |
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
- Generic name (nonproprietary)
- rosuvastatin
- Active ingredients
- Rosuvastatin — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206381
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-796_130008fb-8f9d-0c94-e063-6294a90aebdbSPL ID 130008fb-8f9d-0c94-e063-6294a90aebdbSPL set ID 11701a6e-9b34-4939-e063-6294a90a09c9RxCUI 859751UNII 413KH5ZJ73
- 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
N471610079615followed by a unit qualifier and the quantityPackage 71610-0796-15. 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 stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (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 hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206381
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 | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3847 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-116 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-119 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-117 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-118 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-797 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-798 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2406 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7430 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7431 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4296 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2440 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4303 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4314 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7730 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4057 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7483 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7482 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2498 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-922 |
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