tysabri

Generic: natalizumab

Labeler: biogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tysabri
Generic Name natalizumab
Labeler biogen inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

natalizumab 300 mg/15mL

Manufacturer
Biogen Inc.

Identifiers & Regulatory

Product NDC 64406-008
Product ID 64406-008_119c87a9-d153-4796-9525-694afdcdc1d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125104
Listing Expiration 2026-12-31
Marketing Start 2004-11-23

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 64406008
Hyphenated Format 64406-008

Supplemental Identifiers

RxCUI
477484 603541
UNII
3JB47N2Q2P
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 tysabri (source: ndc)
Generic Name natalizumab (source: ndc)
Application Number BLA125104 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

64406-008-01 1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

natalizumab (300 mg/15mL)

Linked Drug Pages (1)

TYSABRI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "119c87a9-d153-4796-9525-694afdcdc1d6", "openfda": {"nui": ["N0000175775", "N0000175774"], "unii": ["3JB47N2Q2P"], "rxcui": ["477484", "603541"], "spl_set_id": ["c5fdde91-1989-4dd2-9129-4f3323ea2962"], "pharm_class_epc": ["Integrin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Integrin Receptor Antagonists [MoA]"], "manufacturer_name": ["Biogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01)  / 15 mL in 1 VIAL, SINGLE-USE", "package_ndc": "64406-008-01", "marketing_start_date": "20041123"}], "brand_name": "TYSABRI", "product_id": "64406-008_119c87a9-d153-4796-9525-694afdcdc1d6", "dosage_form": "INJECTION", "pharm_class": ["Integrin Receptor Antagonist [EPC]", "Integrin Receptor Antagonists [MoA]"], "product_ndc": "64406-008", "generic_name": "natalizumab", "labeler_name": "Biogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TYSABRI", "active_ingredients": [{"name": "NATALIZUMAB", "strength": "300 mg/15mL"}], "application_number": "BLA125104", "marketing_category": "BLA", "marketing_start_date": "20041123", "listing_expiration_date": "20261231"}