FDA.reportPublic FDA data

Tocilizumab-anoh

Product NDC
72606-051
Requested package NDC
72606-051-04
11-digit product format
726060051
Labeler code
72606
Product ID
72606-051_bacf86b8-9d2f-45d2-9c35-4f619ea494aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tocilizumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761420
Marketing category
BLA
Marketing start
2025-01-26
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
2027-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9f5f0f3b-b458-45da-a406-00e2782d440aProduct name120150818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72606-051-01Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94
72606-051-01Tocilizumab-anoh1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE14
72606-051-02Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94
72606-051-02Tocilizumab-anoh4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE44
72606-051-03Tocilizumab-anoh12 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE124
72606-051-03Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94
72606-051-04Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94
72606-051-04Tocilizumab-anoh1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE14
72606-051-05Tocilizumab-anoh4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE44
72606-051-05Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94
72606-051-06Tocilizumab-anoh12 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE124
72606-051-06Tocilizumab-anoh0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION, CONCENTRATE0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-051TOCILIZUMAB-ANOH (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE [CELLTRION USA, INC.]2Current NDC, 12 package rows20250302_60381a7e-d7ae-4384-925d-c19c418d1663.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVTOZMATOCILIZUMABCELLTRION USA, Inc.581c288f-8015-40ef-a4c3-683c96db193d2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761420

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761420Avtozmatocilizumab-anoh351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705435tocilizumab-anoh 162 MG in 0.9 ML Auto-InjectorPSN60381a7e-d7ae-4384-925d-c19c418d16634
2705425tocilizumab-anoh 162 MG in 0.9 ML Prefilled SyringePSN60381a7e-d7ae-4384-925d-c19c418d16634
2705443tocilizumab-anoh 200 MG in 10 ML InjectionPSN60381a7e-d7ae-4384-925d-c19c418d16634
2705450tocilizumab-anoh 400 MG in 20 ML InjectionPSN60381a7e-d7ae-4384-925d-c19c418d16634
2705452tocilizumab-anoh 80 MG in 4 ML InjectionPSN60381a7e-d7ae-4384-925d-c19c418d16634
27054350.9 ML tocilizumab-anoh 180 MG/ML Auto-InjectorSCD60381a7e-d7ae-4384-925d-c19c418d16634
27054250.9 ML tocilizumab-anoh 180 MG/ML Prefilled SyringeSCD60381a7e-d7ae-4384-925d-c19c418d16634
270544310 ML tocilizumab-anoh 20 MG/ML InjectionSCD60381a7e-d7ae-4384-925d-c19c418d16634
270545020 ML tocilizumab-anoh 20 MG/ML InjectionSCD60381a7e-d7ae-4384-925d-c19c418d16634
27054524 ML tocilizumab-anoh 20 MG/ML InjectionSCD60381a7e-d7ae-4384-925d-c19c418d16634
2705435tocilizumab-anoh 162 MG per 0.9 ML Auto-InjectorSY60381a7e-d7ae-4384-925d-c19c418d16634
2705425tocilizumab-anoh 162 MG per 0.9 ML Prefilled SyringeSY60381a7e-d7ae-4384-925d-c19c418d16634
2705435tocilizumab-anoh 180 MG/ML per 0.9 ML Auto-InjectorSY60381a7e-d7ae-4384-925d-c19c418d16634
2705425tocilizumab-anoh 180 MG/ML per 0.9 ML Prefilled SyringeSY60381a7e-d7ae-4384-925d-c19c418d16634
2705443tocilizumab-anoh 20 MG/ML per 10 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634
2705450tocilizumab-anoh 20 MG/ML per 20 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634
2705452tocilizumab-anoh 20 MG/ML per 4 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634
2705443tocilizumab-anoh 200 MG per 10 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634
2705450tocilizumab-anoh 400 MG per 20 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634
2705452tocilizumab-anoh 80 MG per 4 ML InjectionSY60381a7e-d7ae-4384-925d-c19c418d16634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72606-051-04726060051041 SYRINGE, GLASS in 1 CARTON (72606-051-04) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical