Prescription drug · ANDA
Simvastatin NDC 50090-6390
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6390-0 | 50090639000 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6390-0)Marketed from Mar 9, 2023 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6390_afcb7123-847c-495a-9607-9b9d3f87b651SPL ID afcb7123-847c-495a-9607-9b9d3f87b651SPL set ID 66777aaa-370a-4121-9246-c0866098f4a4RxCUI 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
N450090639000followed by a unit qualifier and the quantityPackage 50090-6390-00. 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 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 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 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5019 |
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