Prescription drug · ANDA
simvastatin NDC 43063-726
Simvastatin 40 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-726-30 | 43063072630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-726-30)Marketed from Nov 7, 2016 | |
| 43063-726-90 | 43063072690 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-726-90)Marketed from Jul 24, 2019 |
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
- PD-Rx Pharmaceuticals, Inc.
- 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 43063-726_51a5a2c0-617d-2186-e063-6394a90acaf2SPL ID 51a5a2c0-617d-2186-e063-6394a90acaf2SPL set ID 7463b093-c2ee-49c3-a08a-e758de66422aRxCUI 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
N443063072630followed by a unit qualifier and the quantityPackage 43063-0726-30. 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 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 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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