Prescription drug · ANDA
Simvastatin NDC 84677-015
Simvastatin 10 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-015-10 | 84677001510 | 1000 TABLET, FILM COATED in 1 BOTTLE (84677-015-10)Marketed from Mar 10, 2026 | |
| 84677-015-90 | 84677001590 | 90 TABLET, FILM COATED in 1 BOTTLE (84677-015-90)Marketed from Mar 10, 2026 |
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 84677-015_4df35a33-0224-6b3b-e063-6294a90ab67cSPL ID 4df35a33-0224-6b3b-e063-6294a90ab67cSPL set ID 4cc35f5f-2d3e-dedd-e063-6294a90a5cbeRxCUI 198211, 200345, 312961, 312962, 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
N484677001510followed by a unit qualifier and the quantityPackage 84677-0015-10. 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)
Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to redu…
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 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 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 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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