Prescription drug · ANDA
Ezetimibe and Simvastatin NDC 51407-192
Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-192-30 | 51407019230 | 30 TABLET in 1 BOTTLE (51407-192-30)Marketed from Apr 29, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200909
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 51407-192_446023ff-25b4-2c12-e063-6294a90ad27eSPL ID 446023ff-25b4-2c12-e063-6294a90ad27eSPL set ID 88cd0e7b-e8dc-6125-e053-2a95a90aaa27RxCUI 476345, 476349, 476350, 476351UNII 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
N451407019230followed by a unit qualifier and the quantityPackage 51407-0192-30. 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 contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are 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 familia…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200909
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 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-190 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-193 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-191 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-744 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-742 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-743 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-745 |