Prescription drug · ANDA
Simvastatin NDC 60687-210
Simvastatin 40 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-210-01 | 60687021001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-210-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-210-11)Marketed from Jun 8, 2016 |
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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 60687-210_35938edc-f896-cc85-e063-6394a90ab210SPL ID 35938edc-f896-cc85-e063-6394a90ab210SPL set ID 51dd8d34-e660-49dc-a86e-07d031a18465RxCUI 198211UNII 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
N460687021001followed by a unit qualifier and the quantityPackage 60687-0210-01. 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 USP 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078103
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 | QPharma, Inc. | 42708-168 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc | 42708-169 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8056 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-421 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-304 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-427 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-320 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-452 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0954 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-511 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-512 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4736 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0628 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9630 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3349 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9636 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7992 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9642 |
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