FDA.reportPublic FDA data

AVTOZMA

Product NDC
72606-042
11-digit product format
726060042
Labeler code
72606
Product ID
72606-042_f9541543-b983-4663-9c9f-c3210efd5f8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tocilizumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761420
Marketing category
BLA
Marketing start
2025-01-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AVTOZMA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB80 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI031V2H011

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
72606-042-01AVTOZMA1 in 1 CARTONINJECTION, SOLUTION14
72606-042-01AVTOZMA4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION44
72606-042-02AVTOZMA4 in 1 CARTONINJECTION, SOLUTION44
72606-042-02AVTOZMA4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-042-01ML - Milliliter72606-04202d3322b-d9cc-4b5d-abeb-060ad4a615e312025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-042AVTOZMA (TOCILIZUMAB) INJECTION, SOLUTION [CELLTRION USA, INC.]2Current NDC, 4 package rows20250221_581c288f-8015-40ef-a4c3-683c96db193d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705439Avtozma 162 MG in 0.9 ML Auto-InjectorPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705432Avtozma 162 MG in 0.9 ML Prefilled SyringePSN581c288f-8015-40ef-a4c3-683c96db193d4
2705448Avtozma 200 MG in 10 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705451Avtozma 400 MG in 20 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705453Avtozma 80 MG in 4 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705435tocilizumab-anoh 162 MG in 0.9 ML Auto-InjectorPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705425tocilizumab-anoh 162 MG in 0.9 ML Prefilled SyringePSN581c288f-8015-40ef-a4c3-683c96db193d4
2705443tocilizumab-anoh 200 MG in 10 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705450tocilizumab-anoh 400 MG in 20 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
2705452tocilizumab-anoh 80 MG in 4 ML InjectionPSN581c288f-8015-40ef-a4c3-683c96db193d4
27054390.9 ML tocilizumab-anoh 180 MG/ML Auto-Injector [Avtozma]SBD581c288f-8015-40ef-a4c3-683c96db193d4
27054320.9 ML tocilizumab-anoh 180 MG/ML Prefilled Syringe [Avtozma]SBD581c288f-8015-40ef-a4c3-683c96db193d4
270544810 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]SBD581c288f-8015-40ef-a4c3-683c96db193d4
270545120 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]SBD581c288f-8015-40ef-a4c3-683c96db193d4
27054534 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]SBD581c288f-8015-40ef-a4c3-683c96db193d4
27054350.9 ML tocilizumab-anoh 180 MG/ML Auto-InjectorSCD581c288f-8015-40ef-a4c3-683c96db193d4
27054250.9 ML tocilizumab-anoh 180 MG/ML Prefilled SyringeSCD581c288f-8015-40ef-a4c3-683c96db193d4
270544310 ML tocilizumab-anoh 20 MG/ML InjectionSCD581c288f-8015-40ef-a4c3-683c96db193d4
270545020 ML tocilizumab-anoh 20 MG/ML InjectionSCD581c288f-8015-40ef-a4c3-683c96db193d4
27054524 ML tocilizumab-anoh 20 MG/ML InjectionSCD581c288f-8015-40ef-a4c3-683c96db193d4
2705439Avtozma 162 MG per 0.9 ML Auto-InjectorSY581c288f-8015-40ef-a4c3-683c96db193d4
2705432Avtozma 162 MG per 0.9 ML Prefilled SyringeSY581c288f-8015-40ef-a4c3-683c96db193d4
2705439Avtozma 180 MG/ML per 0.9 ML Auto-InjectorSY581c288f-8015-40ef-a4c3-683c96db193d4
2705432Avtozma 180 MG/ML per 0.9 ML Prefilled SyringeSY581c288f-8015-40ef-a4c3-683c96db193d4
2705448Avtozma 20 MG/ML per 10 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705451Avtozma 20 MG/ML per 20 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705453Avtozma 20 MG/ML per 4 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705448Avtozma 200 MG per 10 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705451Avtozma 400 MG per 20 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705453Avtozma 80 MG per 4 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705435tocilizumab-anoh 162 MG per 0.9 ML Auto-InjectorSY581c288f-8015-40ef-a4c3-683c96db193d4
2705425tocilizumab-anoh 162 MG per 0.9 ML Prefilled SyringeSY581c288f-8015-40ef-a4c3-683c96db193d4
2705435tocilizumab-anoh 180 MG/ML per 0.9 ML Auto-InjectorSY581c288f-8015-40ef-a4c3-683c96db193d4
2705425tocilizumab-anoh 180 MG/ML per 0.9 ML Prefilled SyringeSY581c288f-8015-40ef-a4c3-683c96db193d4
2705443tocilizumab-anoh 20 MG/ML per 10 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705450tocilizumab-anoh 20 MG/ML per 20 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705452tocilizumab-anoh 20 MG/ML per 4 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705443tocilizumab-anoh 200 MG per 10 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705450tocilizumab-anoh 400 MG per 20 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4
2705452tocilizumab-anoh 80 MG per 4 ML InjectionSY581c288f-8015-40ef-a4c3-683c96db193d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72606-042-01726060042011 VIAL, SINGLE-DOSE in 1 CARTON (72606-042-01) / 4 mL in 1 VIAL, SINGLE-DOSE2025-01-26NoNoHistorical
72606-042-02726060042024 VIAL, SINGLE-DOSE in 1 CARTON (72606-042-02) / 4 mL in 1 VIAL, SINGLE-DOSE2025-01-26NoNoHistorical