Prescription drug · ANDA
ezetimibe and simvastatin NDC 50090-7047
Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7047-0 | 5009070470050090704700 | 90 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
N450090704700followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other ezetimibe and 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) |
|---|---|---|---|---|---|
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-835 | 59651-0835-3059651-0835-90 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-836 | 59651-0836-3059651-0836-90 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-837 | 59651-0837-3059651-0837-90 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-838 | 59651-0838-3059651-0838-90 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | NORTHSTAR RX LLC | 16714-780 | 16714-0780-0116714-0780-02 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | NORTHSTAR RX LLC | 16714-781 | 16714-0781-0116714-0781-02 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-321 | 68462-0321-1068462-0321-3068462-0321-90 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-322 | 68462-0322-1068462-0322-3068462-0322-90 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-323 | 68462-0323-0568462-0323-3068462-0323-90 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-324 | 68462-0324-0568462-0324-3068462-0324-90 |
Other NDCs under ANDA 208699
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 |
|---|---|---|---|---|
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | NORTHSTAR RX LLC | 16714-780 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | NORTHSTAR RX LLC | 16714-781 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-321 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-322 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-323 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-324 |