Prescription drug · ANDA
simvastatin NDC 63629-3408
Simvastatin 80 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3408-1 | 63629340801 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1)Marketed from Aug 8, 2024 | |
| 63629-3408-2 | 63629340802 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2)Marketed from Aug 8, 2024 | |
| 63629-3408-3 | 63629340803 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3)Marketed from Sep 27, 2010 | |
| 63629-3408-4 | 63629340804 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4)Marketed from Feb 18, 2009 | |
| 63629-3408-5 | 63629340805 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5)Marketed from Aug 8, 2024 |
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 — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078155
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-3408_8898906b-2d01-44bb-9ebc-b7c7f30e11a6SPL ID 8898906b-2d01-44bb-9ebc-b7c7f30e11a6SPL set ID b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5RxCUI 200345UNII 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
N463629340801followed by a unit qualifier and the quantityPackage 63629-3408-01. 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)
1. INDICATIONS AND USAGE Simvastatin tablet is 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078155
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 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3393 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3385 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3392 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-050 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-598 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-643 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3391 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-449 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-004 |
| simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-007 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4897 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-005 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-006 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-250 |
| simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7421 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-075 |
| simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-156 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-726 |
| simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-733 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-727 |
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