What is NDC 59651-052?

59651-052 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ezetimibe NDC 59651-052 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-052Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0052Add 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 NDC	11-digit (billing)	Package
59651-052-05	5965100520559651005205	500 TABLET in 1 BOTTLE (59651-052-05)Marketed from Aug 25, 2017
59651-052-30	5965100523059651005230	30 TABLET in 1 BOTTLE (59651-052-30)Marketed from Aug 25, 2017
59651-052-90	5965100529059651005290	90 TABLET in 1 BOTTLE (59651-052-90)Marketed from Aug 25, 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
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209838
Marketing start: Aug 25, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 59651-052_60081062-9f4b-4cf5-9c24-02b5a0b7f792SPL ID 60081062-9f4b-4cf5-9c24-02b5a0b7f792SPL set ID 726b1e63-437a-4b3b-b773-3ac47a5c0f38RxCUI 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

N459651005205 followed by a unit qualifier and the quantity

Package 59651-0052-05. 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 Mar 13, 2025.

Indications (excerpt from the label)

Ezetimibe tablets are 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)

About NDC 59651-052

What is NDC 59651-052?: 59651-052 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Safecor Health, LLC	48433-161	48433-0161-03
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-373	33342-0373-0733342-0373-1033342-0373-15
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-787	10135-0787-0510135-0787-3010135-0787-90
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-024	82009-0024-05
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-628	31722-0628-0131722-0628-0531722-0628-10+4 more
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7689	50090-7689-00
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7690	50090-7690-0050090-7690-01
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-3092	71335-3092-0171335-3092-0271335-3092-03+2 more
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Orient Pharma Co., Ltd.	76333-170	76333-0170-1276333-0170-1376333-0170-14+1 more
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7338	50090-7338-00

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
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	NorthStar Rx LLC	16714-813
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-3422
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-6630
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-6631
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7099
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2123
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Proficient Rx LP	82804-064