FDA.reportPublic FDA data

TYRUKO

Product NDC
61314-543
11-digit product format
613140543
Labeler code
61314
Product ID
61314-543_29c4086f-ca52-4f83-9119-bada7ec65482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
natalizumab-sztn
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
BLA761322
Marketing category
BLA
Marketing start
2025-11-17
Substance
NATALIZUMAB
Active strength
300 mg/15mL
Pharmacologic classes
Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
TYRUKONATALIZUMAB-SZTNSandoz Incef653c36-dd4b-4e71-9d2d-40b8fea24b672025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761322
ndc (product): 61314-543

Additional Listing Data#

Finished product
Yes
Brand name base
TYRUKO
Listing expiration
2027-12-31

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
2725173Internal RxNorm lookup
2725180Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef653c36-dd4b-4e71-9d2d-40b8fea24b67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c2288b8c-527a-4507-83e7-07e683d96cacProduct name120200121
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-543-94TYRUKO1 in 1 CARTONINJECTION113
61314-543-94TYRUKO15 mL in 1 VIAL, SINGLE-DOSEINJECTION1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-543-94ML - Milliliter61314-543e2186770-735d-4ec1-b62d-b37b9b19c32712025-10-14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761322Tyrukonatalizumab-sztn351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725173natalizumab-sztn 300 MG in 15 ML InjectionPSNef653c36-dd4b-4e71-9d2d-40b8fea24b6713
2725180TYRUKO 300 MG in 15 ML InjectionPSNef653c36-dd4b-4e71-9d2d-40b8fea24b6713
272518015 ML natalizumab-sztn 20 MG/ML Injection [Tyruko]SBDef653c36-dd4b-4e71-9d2d-40b8fea24b6713
272517315 ML natalizumab-sztn 20 MG/ML InjectionSCDef653c36-dd4b-4e71-9d2d-40b8fea24b6713
2725173natalizumab-sztn 300 MG per 15 ML InjectionSYef653c36-dd4b-4e71-9d2d-40b8fea24b6713
2725180Tyruko 300 MG per 15 ML InjectionSYef653c36-dd4b-4e71-9d2d-40b8fea24b6713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61314-543-94613140543941 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE2025-11-17NoNoCurrent