FDA.reportPublic FDA data

AVTOZMA

Product NDC
72606-045
11-digit product format
726060045
Labeler code
72606
Product ID
72606-045_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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB162 mg/.9mL

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
72606-045-01AVTOZMA1 in 1 CARTONINJECTION, SOLUTION14
72606-045-01AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94
72606-045-02AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94
72606-045-02AVTOZMA4 in 1 CARTONINJECTION, SOLUTION44
72606-045-03AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94
72606-045-03AVTOZMA12 in 1 CARTONINJECTION, SOLUTION124
72606-045-04AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94
72606-045-04AVTOZMA1 in 1 CARTONINJECTION, SOLUTION14
72606-045-05AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94
72606-045-05AVTOZMA4 in 1 CARTONINJECTION, SOLUTION44
72606-045-06AVTOZMA12 in 1 CARTONINJECTION, SOLUTION124
72606-045-06AVTOZMA0.9 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-045-01ML - Milliliter72606-045ee5c616e-7ecd-4624-ab28-d40734b64fee12026-03-17
72606-045-04ML - Milliliter72606-045ebec463a-2e7c-400f-8a52-0986864c894812026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-045AVTOZMA (TOCILIZUMAB) INJECTION, SOLUTION [CELLTRION USA, INC.]2Current NDC, 12 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
72606-045-01726060045011 SYRINGE, GLASS in 1 CARTON (72606-045-01) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-045-02726060045024 SYRINGE, GLASS in 1 CARTON (72606-045-02) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-045-037260600450312 SYRINGE, GLASS in 1 CARTON (72606-045-03) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-045-04726060045041 SYRINGE, GLASS in 1 CARTON (72606-045-04) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-045-05726060045054 SYRINGE, GLASS in 1 CARTON (72606-045-05) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical
72606-045-067260600450612 SYRINGE, GLASS in 1 CARTON (72606-045-06) / .9 mL in 1 SYRINGE, GLASS2025-01-26NoNoHistorical