Prescription drug · ANDA
Simvastatin NDC 82009-014
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-014-10 | 82009001410 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-014-10)Marketed from May 26, 2022 |
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 200895
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 82009-014_1de47781-9000-0fc1-e063-6294a90a8139SPL ID 1de47781-9000-0fc1-e063-6294a90a8139SPL set ID 2b4255a7-f9f5-4235-8dbb-b0f03acbd624RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EVUPC 0382009015101, 0382009013107, 0382009014104, 0382009012100
- 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
N482009001410followed by a unit qualifier and the quantityPackage 82009-0014-10. 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): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200895
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 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-511 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-510 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-514 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-512 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-513 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-015 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-012 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-013 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-016 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-307 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-305 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-306 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-308 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-309 |