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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NATALIZUMAB	300 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3JB47N2Q2P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c5fdde91-1989-4dd2-9129-4f3323ea2962	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
c2288b8c-527a-4507-83e7-07e683d96cac	Product name	1	20200121
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64406-008-01	TYSABRI	1 in 1 CARTON	INJECTION	1		47
64406-008-01	TYSABRI	15 mL in 1 VIAL, SINGLE-USE	INJECTION	15		47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-008-01	ML - Milliliter	64406-008	f9909e65-7bc5-48b6-8b78-3b17030297fe	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
natalizumab	ACTIVE INGREDIENT	3JB47N2Q2P	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
natalizumab	ACTIVE MOIETY	3JB47N2Q2P	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
sodium phosphate, dibasic, heptahydrate	INACTIVE INGREDIENT	70WT22SF4B	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
sodium phosphate, monobasic, monohydrate	INACTIVE INGREDIENT	593YOG76RN	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22
water	INACTIVE INGREDIENT	059QF0KO0R	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN IDEC INC. ]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-008	TYSABRI (NATALIZUMAB) INJECTION [BIOGEN INC.]	46	Current NDC, Legacy NDC, 2 package rows	20250323_c5fdde91-1989-4dd2-9129-4f3323ea2962.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
TYSABRI	NATALIZUMAB	Biogen Inc.	c5fdde91-1989-4dd2-9129-4f3323ea2962	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125104 ndc (product): 64406-008

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125104	Tysabri	natalizumab	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3JB47N2Q2P	NATALIZUMAB	189261-10-7	NATALIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477484	natalizumab 300 MG in 15 ML Injection	PSN	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
603541	Tysabri 300 MG in 15 ML Injection	PSN	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
603541	15 ML natalizumab 20 MG/ML Injection [Tysabri]	SBD	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
477484	15 ML natalizumab 20 MG/ML Injection	SCD	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
603541	15 ML Tysabri 20 MG/ML Injection	SY	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
477484	natalizumab 300 MG per 15 ML Injection	SY	c5fdde91-1989-4dd2-9129-4f3323ea2962	47
603541	Tysabri 300 MG per 15 ML Injection	SY	c5fdde91-1989-4dd2-9129-4f3323ea2962	47

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-008-01	64406000801	1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USE	2004-11-23	0000-00-00	No	No	Current