Prescription drug · ANDA
Simvastatin NDC 71335-1891
Simvastatin 20 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1891-1 | 7133518910171335189101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1891-1)Marketed from Jul 30, 2021 | |
| 71335-1891-2 | 7133518910271335189102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1891-2)Marketed from Dec 29, 2021 | |
| 71335-1891-3 | 7133518910371335189103 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1891-3)Marketed from Dec 29, 2021 | |
| 71335-1891-4 | 7133518910471335189104 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1891-4)Marketed from Jun 21, 2021 | |
| 71335-1891-5 | 7133518910571335189105 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1891-5)Marketed from Dec 29, 2021 | |
| 71335-1891-6 | 7133518910671335189106 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1891-6)Marketed from Dec 29, 2021 | |
| 71335-1891-7 | 7133518910771335189107 | 3 TABLET, FILM COATED in 1 BOTTLE (71335-1891-7)Marketed from Dec 29, 2021 | |
| 71335-1891-8 | 7133518910871335189108 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1891-8)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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1891_b410c937-f9a1-4089-8ede-265c2dbc32d4SPL ID b410c937-f9a1-4089-8ede-265c2dbc32d4SPL set ID 14bd8444-1556-4636-9e56-28da21a852fcRxCUI 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
N471335189101followed by a unit qualifier and the quantityPackage 71335-1891-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet. Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of total mortality by reducing CHD deaths and reduce the ris…
Excerpt only. Read the full label for complete information.
About NDC 71335-1891
- What is NDC 71335-1891?
- 71335-1891 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simvastatin.
- What is the active ingredient?
- Simvastatin.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simvastatin?
- 156 other product NDCs are listed under this name. See all Simvastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simvastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0628 | 67046-0628-03 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 | 67046-0626-03 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 | 67046-0542-03 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-305 | 72865-0305-0172865-0305-1072865-0305-30+1 more |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-306 | 72865-0306-0172865-0306-1072865-0306-30+1 more |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-307 | 72865-0307-0172865-0307-1072865-0307-30+2 more |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-308 | 72865-0308-0172865-0308-1072865-0308-30+2 more |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-309 | 72865-0309-0172865-0309-0572865-0309-10+3 more |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-376 | 69367-0376-0969367-0376-10 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-374 | 69367-0374-0969367-0374-10 |
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 | A-S Medication Solutions | 50090-6459 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-113 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-448 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-013 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-018 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-026 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-001 |
| 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 80 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc, | 70377-005 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3630 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3648 |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4102 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1905 |
| 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 | 71610-609 |
| 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 |
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