Home NDC 78206-200 TOFIDENCE
Product NDC 78206-200
11-digit product format 782060200
Labeler code 78206
Product ID 78206-200_2fe7ea85-3cb6-4855-9f6e-719611650564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOCILIZUMAB
Dosage form INJECTION
Route INTRAVENOUS
Labeler Organon LLC
Application BLA761354
Marketing category BLA
Marketing start 2025-07-03
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TOFIDENCE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOCILIZUMAB 80 mg/4mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2680287 Internal RxNorm lookup 2680294 Internal RxNorm lookup 2680296 Internal RxNorm lookup 2680297 Internal RxNorm lookup 2680298 Internal RxNorm lookup 2680299 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-200-01 TOFIDENCE 4 mL in 1 VIAL, SINGLE-DOSE INJECTION 4 2 78206-200-01 TOFIDENCE 1 in 1 CARTON INJECTION 1 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761354 Tofidence tocilizumab-bavi 351(k) Biosimilar Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 78206-200-01 78206020001 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-200-01) / 4 mL in 1 VIAL, SINGLE-DOSE 2025-07-03 No No Current