Prescription drug · ANDA
Simvastatin NDC 68180-482
Simvastatin 5 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Simvastatin
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- 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 68180-482_b78d4e8a-2261-43c6-9321-ac2539bdfd2fSPL ID b78d4e8a-2261-43c6-9321-ac2539bdfd2fSPL set ID 3e48217f-8175-4e9b-9fd0-909be4bbba95RxCUI 198211, 200345, 312961, 312962, 314231UNII AGG2FN16EVUPC 0368180478034, 0368180464037, 0368180479031, 0368180465034
- 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.
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.
About NDC 68180-482
- What is NDC 68180-482?
- 68180-482 is the product NDC for Simvastatin, Simvastatin 5 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Simvastatin.
- What is the active ingredient?
- Simvastatin.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simvastatin?
- 155 other product NDCs are listed under this name. See all Simvastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simvastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 | 67046-0626-03 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0628 | 67046-0628-03 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 | 67046-0542-03 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-305 | 72865-0305-0172865-0305-1072865-0305-30+1 more |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-306 | 72865-0306-0172865-0306-1072865-0306-30+1 more |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-307 | 72865-0307-0172865-0307-1072865-0307-30+2 more |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-308 | 72865-0308-0172865-0308-1072865-0308-30+2 more |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-309 | 72865-0309-0172865-0309-0572865-0309-10+3 more |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-374 | 69367-0374-0969367-0374-10 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-375 | 69367-0375-0969367-0375-10 |
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 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7992 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7993 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8056 |
| 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 | A-S Medication Solutions | 50090-4736 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4901 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5788 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6236 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6306 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6307 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6920 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-387 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-459 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4782 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-210 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-579 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-580 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-585 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 |
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