Prescription drug · ANDA
Simvastatin NDC 71335-1905
Simvastatin 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1905-1 | 71335190501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1905-1)Marketed from Sep 8, 2021 | |
| 71335-1905-2 | 71335190502 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1905-2)Marketed from Sep 13, 2021 | |
| 71335-1905-3 | 71335190503 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1905-3)Marketed from Dec 29, 2021 | |
| 71335-1905-4 | 71335190504 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1905-4)Marketed from Jul 19, 2021 | |
| 71335-1905-5 | 71335190505 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1905-5)Marketed from Dec 29, 2021 | |
| 71335-1905-6 | 71335190506 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1905-6)Marketed from Dec 29, 2021 | |
| 71335-1905-7 | 71335190507 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1905-7)Marketed from Dec 29, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-1905_410c02d5-08d3-4fd4-8130-26de1b6daaf2SPL ID 410c02d5-08d3-4fd4-8130-26de1b6daaf2SPL set ID 4277e75a-7f3b-4f35-ae56-0bbe095586a5RxCUI 314231UNII 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
N471335190501followed by a unit qualifier and the quantityPackage 71335-1905-01. 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 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 | Biocon Pharma Inc, | 70377-001 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-005 |
| 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 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-113 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6459 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1891 |
| 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 |
| 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 | 71610-622 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-623 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-015 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-014 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-018 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-016 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-017 |
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