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 Identifiers#

Field, Values table
FieldValues
UniiI031V2H011
Rxcui2679431, 2679438, 2679440, 2679441, 2679442, 2679443

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

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