FDA.reportPublic FDA data

TYENNE

Product NDC
65219-598
11-digit product format
652190598
Labeler code
65219
Product ID
65219-598_87ac5047-4f2b-4571-a8a8-32e08865f379
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tocilizumab-aazg
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761449
Marketing category
BLA
Marketing start
2025-09-01
Substance
TOCILIZUMAB
Active strength
162 mg/.9mL
Pharmacologic classes
Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB162 mg/.9mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I031V2H011Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2686045Internal RxNorm lookup
2686050Internal RxNorm lookup
2686053Internal RxNorm lookup
2686057Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87ac5047-4f2b-4571-a8a8-32e08865f379Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9f5f0f3b-b458-45da-a406-00e2782d440aProduct name120150818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-598-10TYENNE0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.91
65219-598-10TYENNE1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-598-10ML - Milliliter65219-598935045fc-02e6-40ee-864c-6afb8501f03d12025-10-14

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
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLC87ac5047-4f2b-4571-a8a8-32e08865f3792026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761449
ndc (product): 65219-598

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761449Tyennetocilizumab-aazg351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2686045tocilizumab-aazg 162 MG in 0.9 ML Auto-InjectorPSN87ac5047-4f2b-4571-a8a8-32e08865f3791
2686053tocilizumab-aazg 162 MG in 0.9 ML Prefilled SyringePSN87ac5047-4f2b-4571-a8a8-32e08865f3791
2686050Tyenne 162 MG in 0.9 ML Auto-InjectorPSN87ac5047-4f2b-4571-a8a8-32e08865f3791
2686057Tyenne 162 MG in 0.9 ML Prefilled SyringePSN87ac5047-4f2b-4571-a8a8-32e08865f3791
26860500.9 ML tocilizumab-aazg 180 MG/ML Auto-Injector [Tyenne]SBD87ac5047-4f2b-4571-a8a8-32e08865f3791
26860570.9 ML tocilizumab-aazg 180 MG/ML Prefilled Syringe [Tyenne]SBD87ac5047-4f2b-4571-a8a8-32e08865f3791
26860450.9 ML tocilizumab-aazg 180 MG/ML Auto-InjectorSCD87ac5047-4f2b-4571-a8a8-32e08865f3791
26860530.9 ML tocilizumab-aazg 180 MG/ML Prefilled SyringeSCD87ac5047-4f2b-4571-a8a8-32e08865f3791
2686045tocilizumab-aazg 162 MG per 0.9 ML Auto-InjectorSY87ac5047-4f2b-4571-a8a8-32e08865f3791
2686053tocilizumab-aazg 162 MG per 0.9 ML Prefilled SyringeSY87ac5047-4f2b-4571-a8a8-32e08865f3791
2686050Tyenne 162 MG per 0.9 ML Auto-InjectorSY87ac5047-4f2b-4571-a8a8-32e08865f3791
2686057Tyenne 162 MG per 0.9 ML Prefilled SyringeSY87ac5047-4f2b-4571-a8a8-32e08865f3791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-598-10652190598101 SYRINGE, GLASS in 1 CARTON (65219-598-10) / .9 mL in 1 SYRINGE, GLASS2025-09-01NoNoCurrent