Prescription drug · ANDA
Simvastatin NDC 71610-609
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-609-45 | 71610060945 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-609-45)Marketed from Oct 25, 2021 |
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)
- Simvastatin
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-609_ed131a35-eda8-4cdb-a6f0-eae48ea1c59eSPL ID ed131a35-eda8-4cdb-a6f0-eae48ea1c59eSPL set ID c0a303c5-6277-47ce-bb8a-bd5400fd8261RxCUI 198211, 200345, 312961UNII AGG2FN16EV
- 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
N471610060945followed by a unit qualifier and the quantityPackage 71610-0609-45. 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)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet. Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of total mortality by reducing CHD deaths and reduce the ris…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078034
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 |
|---|---|---|---|---|
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-001 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-005 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-002 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-003 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-004 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-113 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6459 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1891 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-610 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-611 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-615 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1906 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1905 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-622 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-623 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-015 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-014 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-018 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-016 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-017 |
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