NDC codes

FDA NDC Directory
Product NDC (as listed)67877-490Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0490Add 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
67877-490-0167877049001100 TABLET in 1 BOTTLE (67877-490-01)Marketed from Dec 23, 2017
67877-490-0567877049005500 TABLET in 1 BOTTLE (67877-490-05)Marketed from Dec 23, 2017
67877-490-306787704903030 TABLET in 1 BOTTLE (67877-490-30)Marketed from Dec 23, 2017
67877-490-55678770490555000 TABLET in 1 BOTTLE (67877-490-55)Marketed from Dec 23, 2017
67877-490-906787704909090 TABLET in 1 BOTTLE (67877-490-90)Marketed from Dec 23, 2017

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
Generic name (nonproprietary)
ezetimibe
Active ingredients
Ezetimibe — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209234
Marketing start
Listing expires
Other FDA classes
Decreased Cholesterol Absorption (Physiologic effect)
Identifiers
Product ID 67877-490_878751ea-5bea-42ef-8f56-2b15a683c7aeSPL ID 878751ea-5bea-42ef-8f56-2b15a683c7aeSPL set ID 206d702c-b09a-4555-972b-6555d6d6d6e6RxCUI 349556UNII EOR26LQQ24
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

N467877049001 followed by a unit qualifier and the quantity

Package 67877-0490-01. 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)

Ezetimibe Tablets 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209234

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209234
ProductStrengthForm · routeLabelerProduct NDC
EzetimibeEzetimibe 10 mg/1TabletOralProficient Rx LP71205-277
EzetimibeEzetimibe 10 mg/1TabletOralMajor Pharmaceuticals0904-7103
EzetimibeEzetimibe 10 mg/1TabletOralBryant Ranch Prepack71335-1127
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-3657
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-7236
EzetimibeEzetimibe 10 mg/1TabletOralAmerican Health Packaging60687-373

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