ENTYVIO Pen (vedolizumab) NDC 64764-108

NDC codes

FDA NDC Directory

Product NDC (as listed)64764-108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64764-0108Add 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	Copy
64764-108-21	64764010821	1 TRAY in 1 CARTON (64764-108-21) / 1 SYRINGE in 1 TRAY (64764-108-20) / .68 mL in 1 SYRINGEMarketed from Sep 27, 2023

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): ENTYVIO Pen
Generic name (nonproprietary): vedolizumab
Active ingredients: Vedolizumab — 108 mg/.68mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761133
Marketing start: Sep 27, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Integrin Receptor Antagonists (Mechanism)
Identifiers: Product ID 64764-108_266293d6-dd28-4e38-81c2-4f518d95ef5dSPL ID 266293d6-dd28-4e38-81c2-4f518d95ef5dSPL set ID 6e94621c-1a95-4af9-98d1-52b9e6f1949cRxCUI 1538137, 1538142, 2667332, 2667336, 2667339, 2667342UNII 9RV78Q2002
Pharmacologic class: Integrin Receptor Antagonist

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N464764010821 followed by a unit qualifier and the quantity

Package 64764-0108-21. 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 Apr 29, 2026.

Indications (excerpt from the label)

ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761133

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

FDA NDC Directory listings under BLA 761133
Product	Strength	Form · route	Labeler	Product NDC
Entyviovedolizumab	Vedolizumab 108 mg/.68mL	Injection, SolutionSubcutaneous	Takeda Pharmaceuticals America, Inc.	64764-107