Prescription drug · ANDA
simvastatin NDC 63187-075
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-075-30 | 63187007530 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-075-30)Marketed from Nov 1, 2018 | |
| 63187-075-60 | 63187007560 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-075-60)Marketed from Nov 1, 2018 | |
| 63187-075-90 | 63187007590 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-075-90)Marketed from Nov 1, 2018 |
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
- Proficient Rx LP
- 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 63187-075_f5e53eb7-8199-4ca7-9cd0-8dc140c79376SPL ID f5e53eb7-8199-4ca7-9cd0-8dc140c79376SPL set ID ca760e79-5d8c-4b36-9899-0d37e8e1f24eRxCUI 198211, 312961, 314231UNII AGG2FN16EVUPC 0363187075903, 0363187191900, 0363187449902
- 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
N463187007530followed by a unit qualifier and the quantityPackage 63187-0075-30. 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.
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 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3408 |
| 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 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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