FDA.reportPublic FDA data

TYSABRI

Product NDC
64406-008
11-digit product format
644060008
Labeler code
64406
Product ID
64406-008_119c87a9-d153-4796-9525-694afdcdc1d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
natalizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Biogen Inc.
Application
BLA125104
Marketing category
BLA
Marketing start
2004-11-23
Substance
NATALIZUMAB
Active strength
300 mg/15mL
Pharmacologic classes
Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYSABRINATALIZUMABBiogen Inc.c5fdde91-1989-4dd2-9129-4f3323ea29622025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125104
ndc (product): 64406-008

Additional Listing Data#

Finished product
Yes
Brand name base
TYSABRI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NATALIZUMAB300 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3JB47N2Q2PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477484Internal RxNorm lookup
603541Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5fdde91-1989-4dd2-9129-4f3323ea2962Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c2288b8c-527a-4507-83e7-07e683d96cacProduct name120200121
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64406-008-01TYSABRI1 in 1 CARTONINJECTION147
64406-008-01TYSABRI15 mL in 1 VIAL, SINGLE-USEINJECTION1547

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-008-01ML - Milliliter64406-008f9909e65-7bc5-48b6-8b78-3b17030297fe12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
natalizumabACTIVE INGREDIENT3JB47N2Q2PTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
natalizumabACTIVE MOIETY3JB47N2Q2PTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
sodium phosphate, dibasic, heptahydrateINACTIVE INGREDIENT70WT22SF4BTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22
waterINACTIVE INGREDIENT059QF0KO0RTYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-008TYSABRI (NATALIZUMAB) INJECTION [BIOGEN INC.]46Current NDC, Legacy NDC, 2 package rows20250323_c5fdde91-1989-4dd2-9129-4f3323ea2962.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125104Tysabrinatalizumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477484natalizumab 300 MG in 15 ML InjectionPSNc5fdde91-1989-4dd2-9129-4f3323ea296247
603541Tysabri 300 MG in 15 ML InjectionPSNc5fdde91-1989-4dd2-9129-4f3323ea296247
60354115 ML natalizumab 20 MG/ML Injection [Tysabri]SBDc5fdde91-1989-4dd2-9129-4f3323ea296247
47748415 ML natalizumab 20 MG/ML InjectionSCDc5fdde91-1989-4dd2-9129-4f3323ea296247
60354115 ML Tysabri 20 MG/ML InjectionSYc5fdde91-1989-4dd2-9129-4f3323ea296247
477484natalizumab 300 MG per 15 ML InjectionSYc5fdde91-1989-4dd2-9129-4f3323ea296247
603541Tysabri 300 MG per 15 ML InjectionSYc5fdde91-1989-4dd2-9129-4f3323ea296247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64406-008-01644060008011 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USE2004-11-230000-00-00NoNoCurrent