Prescription drug · NDA
Vytorin (Ezetimibe and simvastatin) NDC 78206-174
Ezetimibe 10 mg/1; Simvastatin 10 mg/1 · Tablet · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-174-01 | 7820601740178206017401 | 30 TABLET in 1 BOTTLE (78206-174-01)Marketed from Jun 1, 2021 | |
| 78206-174-02 | 7820601740278206017402 | 90 TABLET in 1 BOTTLE (78206-174-02)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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- 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 78206-174_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 AGG2FN16EV, EOR26LQQ24UPC 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
N478206017401followed by a unit qualifier and the quantityPackage 78206-0174-01. 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.
About NDC 78206-174
- What is NDC 78206-174?
- 78206-174 is the product NDC for Vytorin, Ezetimibe 10 mg/1; Simvastatin 10 mg/1 tablet, listed with the FDA by Organon LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vytorin (Ezetimibe and simvastatin).
- What is the active ingredient?
- Ezetimibe, Simvastatin.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vytorin?
- 3 other product NDCs are listed under this name. See all Vytorin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vytorin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Organon LLC | 78206-175 | 78206-0175-0178206-0175-02 |
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Organon LLC | 78206-176 | 78206-0176-0178206-0176-02 |
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Organon LLC | 78206-177 | 78206-0177-0178206-0177-02 |
Other NDCs under NDA 021687
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 |
|---|---|---|---|---|
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Organon LLC | 78206-175 |
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Organon LLC | 78206-176 |
| Vytorinezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Organon LLC | 78206-177 |