avtozma

Generic: tocilizumab

Labeler: celltrion usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name avtozma
Generic Name tocilizumab
Labeler celltrion usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tocilizumab 400 mg/20mL

Manufacturer
CELLTRION USA, Inc.

Identifiers & Regulatory

Product NDC 72606-044
Product ID 72606-044_f9541543-b983-4663-9c9f-c3210efd5f8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761420
Listing Expiration 2027-12-31
Marketing Start 2025-01-26

Pharmacologic Class

Established (EPC)
interleukin-6 receptor antagonist [epc]
Mechanism of Action
interleukin 6 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72606044
Hyphenated Format 72606-044

Supplemental Identifiers

RxCUI
2705425 2705432 2705435 2705439 2705443 2705448 2705450 2705451 2705452 2705453
UNII
I031V2H011
NUI
N0000190478 N0000190480

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name avtozma (source: ndc)
Generic Name tocilizumab (source: ndc)
Application Number BLA761420 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-01) / 20 mL in 1 VIAL, SINGLE-DOSE
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-02) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

72606-044-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-01) / 20 mL in 1 VIAL, SINGLE-DOSE 72606-044-02 4 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-02) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

tocilizumab (400 mg/20mL)

Linked Drug Pages (1)

AVTOZMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f9541543-b983-4663-9c9f-c3210efd5f8a", "openfda": {"nui": ["N0000190478", "N0000190480"], "unii": ["I031V2H011"], "rxcui": ["2705425", "2705432", "2705435", "2705439", "2705443", "2705448", "2705450", "2705451", "2705452", "2705453"], "spl_set_id": ["581c288f-8015-40ef-a4c3-683c96db193d"], "pharm_class_epc": ["Interleukin-6 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 6 Receptor Antagonists [MoA]"], "manufacturer_name": ["CELLTRION USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72606-044-01", "marketing_start_date": "20250126"}, {"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (72606-044-02)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72606-044-02", "marketing_start_date": "20250126"}], "brand_name": "AVTOZMA", "product_id": "72606-044_f9541543-b983-4663-9c9f-c3210efd5f8a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin 6 Receptor Antagonists [MoA]", "Interleukin-6 Receptor Antagonist [EPC]"], "product_ndc": "72606-044", "generic_name": "tocilizumab", "labeler_name": "CELLTRION USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AVTOZMA", "active_ingredients": [{"name": "TOCILIZUMAB", "strength": "400 mg/20mL"}], "application_number": "BLA761420", "marketing_category": "BLA", "marketing_start_date": "20250126", "listing_expiration_date": "20271231"}