AVTOZMA

Product NDC: 72606-043
11-digit product format: 726060043
Labeler code: 72606
Product ID: 72606-043_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: 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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AVTOZMA	TOCILIZUMAB	CELLTRION USA, Inc.	581c288f-8015-40ef-a4c3-683c96db193d	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761420 ndc (product): 72606-043

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOCILIZUMAB	200 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I031V2H011	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581c288f-8015-40ef-a4c3-683c96db193d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9f5f0f3b-b458-45da-a406-00e2782d440a	Product name	1	20150818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72606-043-01	AVTOZMA	1 in 1 CARTON	INJECTION, SOLUTION	1	4
72606-043-01	AVTOZMA	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	4
72606-043-02	AVTOZMA	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	4
72606-043-02	AVTOZMA	4 in 1 CARTON	INJECTION, SOLUTION	4	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72606-043-01	ML - Milliliter	72606-043	8f081937-53f4-4f96-a0fe-f7dfe4ed2f91	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72606-043	AVTOZMA (TOCILIZUMAB) INJECTION, SOLUTION [CELLTRION USA, INC.]	2	Current NDC, 4 package rows	20250221_581c288f-8015-40ef-a4c3-683c96db193d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761420	Avtozma	tocilizumab-anoh	351(k) Interchangeable	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I031V2H011	TOCILIZUMAB	375823-41-9	TOCILIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2705439	Avtozma 162 MG in 0.9 ML Auto-Injector	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 162 MG in 0.9 ML Prefilled Syringe	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 200 MG in 10 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 400 MG in 20 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 80 MG in 4 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 162 MG in 0.9 ML Auto-Injector	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 162 MG in 0.9 ML Prefilled Syringe	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 200 MG in 10 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 400 MG in 20 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 80 MG in 4 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	0.9 ML tocilizumab-anoh 180 MG/ML Auto-Injector [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	0.9 ML tocilizumab-anoh 180 MG/ML Prefilled Syringe [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	10 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	20 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	4 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	0.9 ML tocilizumab-anoh 180 MG/ML Auto-Injector	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	0.9 ML tocilizumab-anoh 180 MG/ML Prefilled Syringe	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	10 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	20 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	4 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	Avtozma 162 MG per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 162 MG per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	Avtozma 180 MG/ML per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 180 MG/ML per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 20 MG/ML per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 20 MG/ML per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 20 MG/ML per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 200 MG per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 400 MG per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 80 MG per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 162 MG per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 162 MG per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 180 MG/ML per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 180 MG/ML per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 20 MG/ML per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 20 MG/ML per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 20 MG/ML per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 200 MG per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 400 MG per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 80 MG per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72606-043-01	72606004301	1 VIAL, SINGLE-DOSE in 1 CARTON (72606-043-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-01-26	No	No	Current
72606-043-02	72606004302	4 VIAL, SINGLE-DOSE in 1 CARTON (72606-043-02) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-01-26	No	No	Current