What is NDC 10135-787?

10135-787 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 10135-787 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-787Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0787Add 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
10135-787-05	1013507870510135078705	500 TABLET in 1 BOTTLE (10135-787-05)Marketed from Jan 1, 2024
10135-787-30	1013507873010135078730	30 TABLET in 1 BOTTLE (10135-787-30)Marketed from Jan 1, 2024
10135-787-90	1013507879010135078790	90 TABLET in 1 BOTTLE (10135-787-90)Marketed from Jan 1, 2024

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: Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215693
Marketing start: Jan 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 10135-787_43046023-125e-85f6-e063-6294a90ab8c7SPL ID 43046023-125e-85f6-e063-6294a90ab8c7SPL set ID 109a22f4-a7cb-96c6-e063-6394a90ad7f6RxCUI 349556UNII EOR26LQQ24UPC 0310135787302, 0310135787906
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

N410135078705 followed by a unit qualifier and the quantity

Package 10135-0787-05. 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 Nov 4, 2026.

Indications (excerpt from the label)

Ezetimibe tablet 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 y…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10135-787

What is NDC 10135-787?: 10135-787 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. 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?: Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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	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
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	A-S Medication Solutions	50090-7339	50090-7339-0050090-7339-01

All 41 Ezetimibe NDCs

Other NDCs under ANDA 215693

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

FDA NDC Directory listings under ANDA 215693
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe	Ezetimibe 10 mg/1	TabletOral	Orient Pharma Co., Ltd.	76333-170