Prescription drug · ANDA
Simvastatin NDC 67046-0626
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0626-3 | 67046062603 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0626-3)Marketed from May 21, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Coupler LLC
- 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 67046-0626_52570354-92e6-3b11-e063-6294a90af4cdSPL ID 52570354-92e6-3b11-e063-6294a90af4cdSPL set ID 5257271e-5c07-4996-e063-6394a90a4424RxCUI 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
N467046062603followed by a unit qualifier and the quantityPackage 67046-0626-03. 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 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 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 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-210 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9642 |
Showing 20 of 39.