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Ontruzant

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Ontruzant
Generic name
Ontruzant
Dosage form
Kit
Route
Intravenous
Marketing category
BLA · BLA
Labeler
Organon LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
1
Packages
1
Data completeness
52% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
Intravenous
Presentations
2

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761100
Application type
BLA · Biologics License Application
Approval date
January 18, 2019
Sponsor
SAMSUNG BIOEPIS CO LTD
Products on application
2
Submissions recorded
5
Products approved under application 761100.
Product Trade name Form Strength Ingredient Status TE Flags
761100-001 ONTRUZANT POWDER TRASTUZUMAB-DTTB Prescription —
761100-002 ONTRUZANT POWDER TRASTUZUMAB-DTTB Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761100.
Type No. Action Status Date Review
Supplement 30 Labeling Approved April 15, 2026 Standard
Supplement 28 Labeling Approved December 5, 2025 Standard
Supplement 25 Bioequivalence Approved February 28, 2025 N/A
Supplement 5 Manufacturing (CMC) Approved March 19, 2020 N/A
Original application 1 Approved January 18, 2019 Standard

Review documents

  • 0 · Supplement · December 9, 2025
  • 0 · Supplement · March 7, 2025
  • 0 · Supplement · March 7, 2025
  • 0 · Supplement · February 7, 2022
  • 0 · Supplement · February 7, 2022
  • 0 · Original application · March 7, 2019
  • 0 · Original application · March 5, 2019
  • 0 · Original application · January 18, 2019

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
78206-148-01 78206-148 Organon LLC 1 KIT in 1 CARTON (78206-148-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99) * 1 INJECTION, SOLUTION in 1 VIAL (78206-149-89) June 1, 2021
78206-148 78206-148 Organon LLC — June 1, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 7 sections on this page.