Prescription drug · NDA
Zetia (Ezetimibe) NDC 78206-178
Ezetimibe 10 mg/1 · Tablet · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-178-01 | 7820601780178206017801 | 30 TABLET in 1 BOTTLE (78206-178-01)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)
- Zetia
- Generic name (nonproprietary)
- ezetimibe
- Active ingredients
- Ezetimibe — 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 021445
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 78206-178_8e5eed2a-7b64-4350-9b87-500f1b04225dSPL ID 8e5eed2a-7b64-4350-9b87-500f1b04225dSPL set ID 174e45e0-45bb-48b7-9e60-8f6cfc1d22bbRxCUI 349556, 352304UNII EOR26LQQ24UPC 0378206178015
- Pharmacologic class
- Dietary Cholesterol Absorption 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
N478206017801followed by a unit qualifier and the quantityPackage 78206-0178-01. 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)
ZETIA ® is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of a…
Excerpt only. Read the full label for complete information.
About NDC 78206-178
- What is NDC 78206-178?
- 78206-178 is the product NDC for Zetia (ezetimibe), Ezetimibe 10 mg/1 tablet, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zetia (Ezetimibe).
- What is the active ingredient?
- Ezetimibe.
- 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 Zetia?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.