FDA.reportPublic FDA data

Tocilizumab-anoh

Product NDC
72606-049
11-digit product format
726060049
Labeler code
72606
Product ID
72606-049_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
200 mg/10mL
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
72606-049-01Tocilizumab-anoh10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE104
72606-049-01Tocilizumab-anoh1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE14
72606-049-02Tocilizumab-anoh4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE44
72606-049-02Tocilizumab-anoh10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-049TOCILIZUMAB-ANOH (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE [CELLTRION USA, INC.]2Current NDC, 4 package rows20250302_60381a7e-d7ae-4384-925d-c19c418d1663.zip

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
72606-049-01726060049011 VIAL, SINGLE-DOSE in 1 CARTON (72606-049-01) / 10 mL in 1 VIAL, SINGLE-DOSE2025-01-26NoNoHistorical
72606-049-02726060049024 VIAL, SINGLE-DOSE in 1 CARTON (72606-049-02) / 10 mL in 1 VIAL, SINGLE-DOSE2025-01-26NoNoHistorical