FDA.reportPublic FDA data

Tocilizumab-anoh

Product NDC
72606-051
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761420Avtozmatocilizumab-anoh351(k) InterchangeableRx2026-06-01

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
72606-051-01726060051011 SYRINGE, GLASS in 1 CARTON (72606-051-01) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-051-02726060051024 SYRINGE, GLASS in 1 CARTON (72606-051-02) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-051-037260600510312 SYRINGE, GLASS in 1 CARTON (72606-051-03) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-051-04726060051041 SYRINGE, GLASS in 1 CARTON (72606-051-04) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-051-05726060051054 SYRINGE, GLASS in 1 CARTON (72606-051-05) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-051-067260600510612 SYRINGE, GLASS in 1 CARTON (72606-051-06) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical