entyvio pen

Generic: vedolizumab

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name entyvio pen
Generic Name vedolizumab
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

vedolizumab 108 mg/.68mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-108
Product ID 64764-108_24e7cbcf-82ec-4276-ba13-e719bedf3ed2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761133
Listing Expiration 2027-12-31
Marketing Start 2023-09-27

Pharmacologic Class

Established (EPC)
integrin receptor antagonist [epc]
Mechanism of Action
integrin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764108
Hyphenated Format 64764-108

Supplemental Identifiers

RxCUI
1538137 1538142 2667332 2667336 2667339 2667342
UNII
9RV78Q2002
NUI
N0000175775 N0000175774

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name entyvio pen (source: ndc)
Generic Name vedolizumab (source: ndc)
Application Number BLA761133 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 108 mg/.68mL
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (64764-108-21) / 1 SYRINGE in 1 TRAY (64764-108-20) / .68 mL in 1 SYRINGE
source: ndc

Packages (1)

64764-108-21 1 TRAY in 1 CARTON (64764-108-21) / 1 SYRINGE in 1 TRAY (64764-108-20) / .68 mL in 1 SYRINGE

Ingredients (1)

vedolizumab (108 mg/.68mL)

Linked Drug Pages (1)

ENTYVIO, ENTYVIO Pen, Entyvio ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "24e7cbcf-82ec-4276-ba13-e719bedf3ed2", "openfda": {"nui": ["N0000175775", "N0000175774"], "unii": ["9RV78Q2002"], "rxcui": ["1538137", "1538142", "2667332", "2667336", "2667339", "2667342"], "spl_set_id": ["6e94621c-1a95-4af9-98d1-52b9e6f1949c"], "pharm_class_epc": ["Integrin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Integrin Receptor Antagonists [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (64764-108-21)  / 1 SYRINGE in 1 TRAY (64764-108-20)  / .68 mL in 1 SYRINGE", "package_ndc": "64764-108-21", "marketing_start_date": "20230927"}], "brand_name": "ENTYVIO Pen", "product_id": "64764-108_24e7cbcf-82ec-4276-ba13-e719bedf3ed2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Integrin Receptor Antagonist [EPC]", "Integrin Receptor Antagonists [MoA]"], "product_ndc": "64764-108", "generic_name": "vedolizumab", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENTYVIO Pen", "active_ingredients": [{"name": "VEDOLIZUMAB", "strength": "108 mg/.68mL"}], "application_number": "BLA761133", "marketing_category": "BLA", "marketing_start_date": "20230927", "listing_expiration_date": "20271231"}