Prescription drug · ANDA
Simvastatin NDC 31722-511
Simvastatin 10 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-511-01 | 31722051101 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-511-01)Marketed from Dec 9, 2014 | |
| 31722-511-10 | 31722051110 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-511-10)Marketed from Dec 9, 2014 | |
| 31722-511-30 | 31722051130 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-511-30)Marketed from Dec 9, 2014 | |
| 31722-511-90 | 31722051190 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-511-90)Marketed from Dec 9, 2014 |
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
- Labeler
- Camber Pharmaceuticals, Inc.
- 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 31722-511_1553d57f-414d-2c66-e063-6294a90af8e0SPL ID 1553d57f-414d-2c66-e063-6294a90af8e0SPL set ID 751b79c6-bba8-4d29-b69c-a2ac6453fec8RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EVUPC 0331722511308, 0331722510301
- 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
N431722051101followed by a unit qualifier and the quantityPackage 31722-0511-01. 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 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 20 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-014 |
| 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 |