Prescription drug · NDA
Vytorin NDC 78206-175
ezetimibe and simvastatin · Ezetimibe 10 mg/1; Simvastatin 20 mg/1 · Tablet · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-175-01 | 78206017501 | 30 TABLET in 1 BOTTLE (78206-175-01)Marketed from Jun 1, 2021 | |
| 78206-175-02 | 78206017502 | 90 TABLET in 1 BOTTLE (78206-175-02)Marketed from Jun 1, 2021 |
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)
- Vytorin
- Generic name (nonproprietary)
- ezetimibe and simvastatin
- Active ingredients
- Ezetimibe — 10 mg/1Simvastatin — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021687
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 78206-175_9e668c78-ea5d-4099-ba16-b77aebbcb68aSPL ID 9e668c78-ea5d-4099-ba16-b77aebbcb68aSPL set ID 89b860d2-de83-468e-b7e8-76aeec2edca2RxCUI 476345, 476349, 476350, 476351, 1245420, 1245430, 1245441, 1245449UNII EOR26LQQ24, AGG2FN16EVUPC 0378206174017, 0378206175014, 0378206176011, 0378206177018
- 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
N478206017501followed by a unit qualifier and the quantityPackage 78206-0175-01. 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)
VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of VYTORIN, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary …
Excerpt only. Read the full label for complete information.