Home NDC 64764-108 ENTYVIO Pen
Product NDC 64764-108
11-digit product format 647640108
Labeler code 64764
Product ID 64764-108_266293d6-dd28-4e38-81c2-4f518d95ef5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vedolizumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Takeda Pharmaceuticals America, Inc.
Application BLA761133
Marketing category BLA
Marketing start 2023-09-27
Substance VEDOLIZUMAB
Active strength 108 mg/.68mL
Pharmacologic classes Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ENTYVIO Pen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VEDOLIZUMAB 108 mg/.68mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9RV78Q2002 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1538137 Internal RxNorm lookup 1538142 Internal RxNorm lookup 2667332 Internal RxNorm lookup 2667336 Internal RxNorm lookup 2667339 Internal RxNorm lookup 2667342 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64764-108-20 ENTYVIO Pen 0.68 mL in 1 SYRINGE INJECTION, SOLUTION 0.68 26 64764-108-20 ENTYVIO Pen 1 in 1 TRAY INJECTION, SOLUTION 1 26 64764-108-21 ENTYVIO Pen 1 in 1 CARTON INJECTION, SOLUTION 1 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VEDOLIZUMAB ACTIVE INGREDIENT 9RV78Q2002 ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 VEDOLIZUMAB ACTIVE MOIETY 9RV78Q2002 ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 ARGININE HYDROCHLORIDE INACTIVE INGREDIENT F7LTH1E20Y ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 HISTIDINE INACTIVE INGREDIENT 4QD397987E ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 HISTIDINE MONOHYDROCHLORIDE INACTIVE INGREDIENT 1D5Q932XM6 ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-108 ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ENTYVIO PEN (VEDOLIZUMAB) INJECTION, SOLUTION ENTYVIO (VEDOLIZUMAB) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 20 Current NDC, 3 package rows 20240612_6e94621c-1a95-4af9-98d1-52b9e6f1949c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENTYVIO VEDOLIZUMAB Takeda Pharmaceuticals America, Inc. 6e94621c-1a95-4af9-98d1-52b9e6f1949c 2026-04-29 Warnings, Adverse reactions Exact identifier application number: BLA761133 ndc (product): 64764-108
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761133 Entyvio vedolizumab 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64764-108-20 64764010820 0.68 mL in 1 SYRINGE 0.68 ml Historical 64764-108-21 64764010821 1 TRAY in 1 CARTON (64764-108-21) / 1 SYRINGE in 1 TRAY (64764-108-20) / .68 mL in 1 SYRINGE 1 tray 2023-09-27 No No Current