Ontruzant

Product NDC: 0006-5034
Requested package NDC: 0006-5034-02
11-digit product format: 000065034
Labeler code: 0006
Product ID: 0006-5034_419c4f97-e6d6-4bed-9014-a69a39d2149f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ontruzant
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Merck Sharp & Dohme Corp.
Application: BLA761100
Marketing category: BLA
Marketing start: 2020-04-15
Marketing end: 2023-09-30
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0006-5034	0006-5034-02	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-5034-02	EA - Each	0006-5034	71328042-1980-441d-8701-dd4663e6c001	1	2020-05-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ontruzant	TRASTUZUMAB	Organon LLC	ce2a2492-85e3-4b0a-872a-047f44e4203d	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761100

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761100	Ontruzant	trastuzumab-dttb	351(k) Biosimilar	Rx	2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-5034-02	00006503402	1 KIT in 1 CARTON (0006-5034-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE * 1 INJECTION, SOLUTION in 1 VIAL	1 kit	2020-04-15	2023-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ontruzant	Merck Sharp & Dohme Corp. \| Samsung Bioepis Co., Ltd.	2020-04-02	HUMAN PRESCRIPTION DRUG LABEL	7