Prescription drug · ANDA
Simvastatin NDC 51655-448
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-448-26 | 51655044826 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-448-26)Marketed from Oct 13, 2020 | |
| 51655-448-52 | 51655044852 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-448-52)Marketed from Feb 22, 2023 |
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
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 51655-448_4b44a532-fceb-f2c4-e063-6394a90a9512SPL ID 4b44a532-fceb-f2c4-e063-6394a90a9512SPL set ID f2f5ee7a-4f4e-12e9-e053-2a95a90a7eaeRxCUI 312961UNII 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
N451655044826followed by a unit qualifier and the quantityPackage 51655-0448-26. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 51655-448
- What is NDC 51655-448?
- 51655-448 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simvastatin.
- What is the active ingredient?
- Simvastatin.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. 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 078034
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 | A-S Medication Solutions | 50090-6459 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-113 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-013 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-018 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-026 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-001 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-002 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-003 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-004 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-005 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3630 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3648 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4102 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1891 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1905 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1906 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-609 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-610 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-611 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-615 |
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