NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7047Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7047Add 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
50090-7047-0500907047005009070470090 TABLET in 1 BOTTLE (50090-7047-0)Marketed from Jan 15, 2024

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)
ezetimibe and simvastatin
Generic name (nonproprietary)
ezetimibe and simvastatin
Active ingredients
Ezetimibe — 10 mg/1Simvastatin — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208699
Marketing start
Listing expires
Other FDA classes
Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50090-7047_2a454f7c-e824-4504-b2e8-5fce64b1065aSPL ID 2a454f7c-e824-4504-b2e8-5fce64b1065aSPL set ID 2c936363-b483-46c6-936c-a07d8ab0280cRxCUI 476350UNII EOR26LQQ24, AGG2FN16EV
Pharmacologic class
Dietary Cholesterol Absorption Inhibitor; 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

N450090704700 followed by a unit qualifier and the quantity

Package 50090-7047-00. 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. Ezetimibe and simvastatin tablets, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous famil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-7047

What is NDC 50090-7047?
50090-7047 is the product NDC for ezetimibe and simvastatin, Ezetimibe 10 mg/1; Simvastatin 40 mg/1 tablet, 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?
ezetimibe and simvastatin.
What is the active ingredient?
Ezetimibe, 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 ezetimibe and simvastatin?
23 other product NDCs are listed under this name. See all ezetimibe and 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 ezetimibe and simvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralAurobindo Pharma Limited59651-83559651-0835-3059651-0835-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 20 mg/1TabletOralAurobindo Pharma Limited59651-83659651-0836-3059651-0836-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralAurobindo Pharma Limited59651-83759651-0837-3059651-0837-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralAurobindo Pharma Limited59651-83859651-0838-3059651-0838-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralNORTHSTAR RX LLC16714-78016714-0780-0116714-0780-02
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralNORTHSTAR RX LLC16714-78116714-0781-0116714-0781-02
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32168462-0321-1068462-0321-3068462-0321-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 20 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32268462-0322-1068462-0322-3068462-0322-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32368462-0323-0568462-0323-3068462-0323-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32468462-0324-0568462-0324-3068462-0324-90

All 24 ezetimibe and simvastatin NDCs

Other NDCs under ANDA 208699

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

FDA NDC Directory listings under ANDA 208699
ProductStrengthForm · routeLabelerProduct NDC
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralNORTHSTAR RX LLC16714-780
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralNORTHSTAR RX LLC16714-781
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-321
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 20 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-322
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-323
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-324

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