NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2123Add 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
71335-2123-1713352123017133521230130 TABLET in 1 BOTTLE (71335-2123-1)Marketed from Aug 31, 2022
71335-2123-2713352123027133521230290 TABLET in 1 BOTTLE (71335-2123-2)Marketed from Aug 24, 2022
71335-2123-3713352123037133521230328 TABLET in 1 BOTTLE (71335-2123-3)Marketed from Apr 3, 2024
71335-2123-4713352123047133521230418 TABLET in 1 BOTTLE (71335-2123-4)Marketed from Apr 3, 2024
71335-2123-5713352123057133521230560 TABLET in 1 BOTTLE (71335-2123-5)Marketed from Nov 22, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209838
Marketing start
Listing expires
Other FDA classes
Decreased Cholesterol Absorption (Physiologic effect)
Identifiers
Product ID 71335-2123_34f7bf4b-9cfb-6931-e063-6394a90abab1SPL ID 34f7bf4b-9cfb-6931-e063-6394a90abab1SPL set ID 3a80b668-51cd-42be-8497-8712b0508422RxCUI 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

N471335212301 followed by a unit qualifier and the quantity

Package 71335-2123-01. 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 tabletsareindicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy isnot 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 todiet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct todiet to reduce elevated LDL-C in adults with mixed hyperlipidemia. In combination with a statin, and other LDL-C lowering therapies, toreduce elevated LDL-C levels in adults and in pediatric patients 10 years…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2123

What is NDC 71335-2123?
71335-2123 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ezetimibe.
What is the active ingredient?
Ezetimibe.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ezetimibe?
40 other product NDCs are listed under this name. See all Ezetimibe NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ezetimibe NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ezetimibeEzetimibe 10 mg/1TabletOralSafecor Health, LLC48433-16148433-0161-03
EzetimibeEzetimibe 10 mg/1TabletOralMacleods Pharmaceuticals Limited33342-37333342-0373-0733342-0373-1033342-0373-15
EzetimibeEzetimibe 10 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-78710135-0787-0510135-0787-3010135-0787-90
ezetimibeEzetimibe 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-02482009-0024-05
EzetimibeEzetimibe 10 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-62831722-0628-0131722-0628-0531722-0628-10+4 more
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-768950090-7689-00
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-769050090-7690-0050090-7690-01
EzetimibeEzetimibe 10 mg/1TabletOralBryant Ranch Prepack71335-309271335-3092-0171335-3092-0271335-3092-03+2 more
EzetimibeEzetimibe 10 mg/1TabletOralOrient Pharma Co., Ltd.76333-17076333-0170-1276333-0170-1376333-0170-14+1 more
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-733850090-7338-00

All 41 Ezetimibe NDCs

Other NDCs under ANDA 209838

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

FDA NDC Directory listings under ANDA 209838
ProductStrengthForm · routeLabelerProduct NDC
EzetimibeEzetimibe 10 mg/1TabletOralNorthStar Rx LLC16714-813
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-3422
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-6630
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-6631
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-7099
EzetimibeEzetimibe 10 mg/1TabletOralAurobindo Pharma Limited59651-052
EzetimibeEzetimibe 10 mg/1TabletOralProficient Rx LP82804-064

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