Prescription drug · ANDA
Simvastatin NDC 70518-0954
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0954-0 | 70518095400 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0954-0)Marketed from Jan 12, 2018 |
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
- REMEDYREPACK INC.
- 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 70518-0954_4989e76d-a98b-f08c-e063-6294a90a4d2bSPL ID 4989e76d-a98b-f08c-e063-6294a90a4d2bSPL set ID 30fe2447-4dd3-43e6-bac5-0f754ab77c3aRxCUI 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
N470518095400followed by a unit qualifier and the quantityPackage 70518-0954-00. 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 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 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 |
| 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 |
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