NDC codes

FDA NDC Directory
Product NDC (as listed)78206-178Labeler and product segments. Claims need a package NDC.
Product NDC at billing width78206-0178Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
78206-178-01782060178017820601780130 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

N478206017801 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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