Prescription drug · ANDA
Simvastatin NDC 68071-2559
Simvastatin 40 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2559-3 | 68071255903 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2559-3)Marketed from Oct 29, 2021 |
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)
- Simvastatin
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077691
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2559_2dcc5a08-ac32-cd35-e063-6294a90a8524SPL ID 2dcc5a08-ac32-cd35-e063-6294a90a8524SPL set ID cf859977-2d84-0fcb-e053-2a95a90a6269RxCUI 198211UNII AGG2FN16EVUPC 0368071255935
- 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
N468071255903followed by a unit qualifier and the quantityPackage 68071-2559-03. 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 tablets can be started simultaneously with diet. Simvastatin tablets are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077691
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 40 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-684 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-682 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-683 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-685 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6389 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6390 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6421 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6424 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6425 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7088 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4801 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7776 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7782 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7777 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7780 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7781 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-052 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7783 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-050 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-051 |
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