FDA.reportPublic FDA data

TYENNE

Product NDC
65219-590
11-digit product format
652190590
Labeler code
65219
Product ID
65219-590_c6e5034e-6d33-4c6f-bb0e-d03bea292c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tocilizumab-aazg
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761275
Marketing category
BLA
Marketing start
2024-04-15
Substance
TOCILIZUMAB
Active strength
80 mg/4mL
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB80 mg/4mL

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2679431Internal RxNorm lookup
2679438Internal RxNorm lookup
2679440Internal RxNorm lookup
2679441Internal RxNorm lookup
2679442Internal RxNorm lookup
2679443Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e400bbe6-43c5-4de6-82b9-cb44ce3cd906Available 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
65219-590-04TYENNE1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE12
65219-590-04TYENNE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-590-04ML - Milliliter65219-5901e5264a4-5cdd-43a8-a793-73fb9676dcda12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-590TYENNE (TOCILIZUMAB-AAZG) INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20250210_e400bbe6-43c5-4de6-82b9-cb44ce3cd906.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLCad76441d-da59-47df-8d9d-2243005180f02026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761275
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLCe400bbe6-43c5-4de6-82b9-cb44ce3cd9062024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761275
ndc (product): 65219-590

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761275Tyennetocilizumab-aazg351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679440tocilizumab-aazg 200 MG in 10 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679442tocilizumab-aazg 400 MG in 20 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679431tocilizumab-aazg 80 MG in 4 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679441Tyenne 200 MG in 10 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679443Tyenne 400 MG in 20 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679438Tyenne 80 MG in 4 ML InjectionPSNe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944110 ML tocilizumab-aazg 20 MG/ML Injection [Tyenne]SBDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944320 ML tocilizumab-aazg 20 MG/ML Injection [Tyenne]SBDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
26794384 ML tocilizumab-aazg 20 MG/ML Injection [Tyenne]SBDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944010 ML tocilizumab-aazg 20 MG/ML InjectionSCDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944220 ML tocilizumab-aazg 20 MG/ML InjectionSCDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
26794314 ML tocilizumab-aazg 20 MG/ML InjectionSCDe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944110 ML Tyenne 20 MG/ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
267944320 ML Tyenne 20 MG/ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
26794384 ML Tyenne 20 MG/ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679440tocilizumab-aazg 200 MG per 10 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679442tocilizumab-aazg 400 MG per 20 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679431tocilizumab-aazg 80 MG per 4 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679441Tyenne 200 MG per 10 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679443Tyenne 400 MG per 20 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062
2679438Tyenne 80 MG per 4 ML InjectionSYe400bbe6-43c5-4de6-82b9-cb44ce3cd9062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-590-04652190590041 VIAL, SINGLE-DOSE in 1 CARTON (65219-590-04) / 4 mL in 1 VIAL, SINGLE-DOSE2024-04-15NoNoCurrent