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

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

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
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761322Tyrukonatalizumab-sztn351(k) BiosimilarRx2026-08-01

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