ENTYVIO J Code: J3380

Drug & Product Overview

HCPCS Descriptor Injection, vedolizumab, intravenous, 1 mg

HCPCS Added Date January 1, 2016

Manufacturer Takeda Pharmaceuticals

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection, Powder, Lyophilized, For Solution

About ENTYVIO

Entyvio is a medication aligned to the HCPCS J Code: J3380 for billing, pricing, and reimbursement purposes in the United States. Classified under Immunology, it is administered via the intravenous route and manufactured by Takeda Pharmaceuticals.

According to CMS Drug Use Information: This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
64764-0300-20	Entyvio	Takeda Pharmaceuticals America, Inc.	300	300 MG / 5 ML

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ENTYVIO Pricing & Reimbursement

J3380 Private Payer Reimbursement

$21.40 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

per HCPCS unit

As of Q4 2026

ENTYVIO Claims Performance

Claims from Jan 2026 – Aug 2026

Claim Denial Rate 14.08%

Avg. Days to File 6.8days

Avg. Days to Pay 21.4days

Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.

Explore J3380 claims analytics on FocalPoint →

ENTYVIO CPT Administration Codes

CPT Code	Description
96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
96366	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)
96372 Login for More	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular Login for More

JW / JZ modifiers apply

CMS has identified Entyvio (J3380) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →

ENTYVIO Medically Unlikely Edits (MUE)

The most billing units of J3380 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.

Practitioner Office & Hospital Outpatient

300 units / day

= 300 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

ENTYVIO Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Crohn's Disease Ulcerative Colitis

Drug Class

Integrin Receptor Antagonist [EPC]Integrin Receptor Antagonists [MoA]

Frequently Asked Questions

Is there an available Entyvio billing and coding guide?

Billing and coding information for ENTYVIO can be found through Takeda. Visit Here →

Are there any available Entyvio patient assistance programs?

ENTYVIO patient assistance information can be found through Takeda. Visit Here →

Where can I find Entyvio prescribing information?

ENTYVIO prescribing information can be found at the link below: Visit Here →

Where can I find Entyvio side effect information?

Information regarding ENTYVIO's side effects can be found at MedlinePlus Visit Here →

Does billing ENTYVIO require JZ/JW wastage modifiers?

CMS has identified ENTYVIO(J3380) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. See CMS guidelines on use of the JZ and JW wastage modifiers below.

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