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HERCESSI

Trastuzumab-strf · Injection, Powder, Lyophilized, for Solution

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

HERCESSI

Generic name

Trastuzumab-strf

Dosage form

Injection, Powder, Lyophilized, for Solution

Route

Intravenous

Marketing category

BLA · BLA

Labeler

Accord BioPharma Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

52% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Trastuzumab-Strf	150 mg/7.4mL	—	—
Trastuzumab-Strf	420 mg/20mL	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection, Powder, Lyophilized, for Solution

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
HER2/Neu/cerbB2 Antagonists [MoA]	MoA	6 members — no class page
HER2/neu Receptor Antagonist [EPC]	EPC	6 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

761346

Application type

BLA · Biologics License Application

Approval date

April 25, 2024

Sponsor

ACCORD BIOPHARMA INC.

Products on application

Submissions recorded

Products approved under application 761346.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
761346-001	HERCESSI	INJECTABLE		TRASTUZUMAB-STRF	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 761346.
Type	No.	Action	Status	Date	Review
Supplement	1	Manufacturing (CMC)	Approved	September 6, 2024	N/A
Original application	1		Approved	April 25, 2024	Standard

Review documents

0 · Supplement · September 9, 2024
0 · Original application · August 9, 2024
0 · Original application · April 25, 2024
0 · Original application · April 25, 2024

Adverse event reports

Source: openFDA FAERS

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

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
69448-015-05	69448-015	Accord BioPharma Inc.	1 VIAL, SINGLE-DOSE in 1 CARTON (69448-015-05) / 7.4 mL in 1 VIAL, SINGLE-DOSE	January 1, 2025
69448-016-11	69448-016	Accord BioPharma Inc.	1 VIAL, MULTI-DOSE in 1 CARTON (69448-016-11) / 20 mL in 1 VIAL, MULTI-DOSE	January 1, 2025
69448-015	69448-015	Accord BioPharma Inc.	—	January 1, 2025
69448-016	69448-016	Accord BioPharma Inc.	—	January 1, 2025

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 · 8 sections on this page.