tofidence

Generic: tocilizumab

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tofidence
Generic Name tocilizumab
Labeler organon llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

tocilizumab 200 mg/10mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-201
Product ID 78206-201_2fe7ea85-3cb6-4855-9f6e-719611650564
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761354
Listing Expiration 2026-12-31
Marketing Start 2025-07-03

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 78206201
Hyphenated Format 78206-201

Supplemental Identifiers

RxCUI
2680287 2680294 2680296 2680297 2680298 2680299
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 tofidence (source: ndc)
Generic Name tocilizumab (source: ndc)
Application Number BLA761354 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-201-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

78206-201-01 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-201-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

tocilizumab (200 mg/10mL)

Linked Drug Pages (1)

TOFIDENCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2fe7ea85-3cb6-4855-9f6e-719611650564", "openfda": {"nui": ["N0000190478", "N0000190480"], "unii": ["I031V2H011"], "rxcui": ["2680287", "2680294", "2680296", "2680297", "2680298", "2680299"], "spl_set_id": ["1ab3207a-ebfe-4565-9ce5-3a1538815c83"], "pharm_class_epc": ["Interleukin-6 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 6 Receptor Antagonists [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (78206-201-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "78206-201-01", "marketing_start_date": "20250703"}], "brand_name": "TOFIDENCE", "product_id": "78206-201_2fe7ea85-3cb6-4855-9f6e-719611650564", "dosage_form": "INJECTION", "pharm_class": ["Interleukin 6 Receptor Antagonists [MoA]", "Interleukin-6 Receptor Antagonist [EPC]"], "product_ndc": "78206-201", "generic_name": "TOCILIZUMAB", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOFIDENCE", "active_ingredients": [{"name": "TOCILIZUMAB", "strength": "200 mg/10mL"}], "application_number": "BLA761354", "marketing_category": "BLA", "marketing_start_date": "20250703", "listing_expiration_date": "20261231"}