NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6459Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6459Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-6459-0500906459005009064590030 TABLET, FILM COATED in 1 BOTTLE (50090-6459-0)Marketed from May 1, 2023

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
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 50090-6459_a6bec4e9-7e8c-42b5-861b-4bf87b934118SPL ID a6bec4e9-7e8c-42b5-861b-4bf87b934118SPL set ID 34c8c080-97b5-4580-b8fb-3fd557cdb40aRxCUI 312962UNII 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

N450090645900 followed by a unit qualifier and the quantity

Package 50090-6459-00. 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

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.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6459

What is NDC 50090-6459?
50090-6459 is the product NDC for Simvastatin, Simvastatin 5 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, 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?
A-S Medication Solutions, NDC labeler code 50090. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Simvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralCoupler LLC67046-062867046-0628-03
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralCoupler LLC67046-062667046-0626-03
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-054267046-0542-03
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30572865-0305-0172865-0305-1072865-0305-30+1 more
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30672865-0306-0172865-0306-1072865-0306-30+1 more
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30772865-0307-0172865-0307-1072865-0307-30+2 more
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30872865-0308-0172865-0308-1072865-0308-30+2 more
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30972865-0309-0172865-0309-0572865-0309-10+3 more
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37669367-0376-0969367-0376-10
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37469367-0374-0969367-0374-10

All 157 Simvastatin NDCs

Other NDCs under ANDA 078034

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078034
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-113
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-448
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-013
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-018
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-026
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-001
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-002
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-003
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-004
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-005
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3630
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3648
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4102
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1891
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1905
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1906
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-609
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-610
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-611
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-615

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