Prescription drug · ANDA
Simvastatin NDC 71610-615
Simvastatin 10 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-615-45 | 71610061545 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-615-45)Marketed from Nov 2, 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 — 10 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 71610-615_f4ad952e-eb20-44b8-aff0-f7aac8ec7690SPL ID f4ad952e-eb20-44b8-aff0-f7aac8ec7690SPL set ID 37860f3f-984e-419a-a262-3bacc766953eRxCUI 314231UNII 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
N471610061545followed by a unit qualifier and the quantityPackage 71610-0615-45. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-609 |
| 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 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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