gemtuzumab ozogamicin 4.5 MG Injection

RxCUI: 1944701
RxNorm name: gemtuzumab ozogamicin 4.5 MG Injection
Display name: gemtuzumab ozogamicin 4.5 MG Injection
Full name: gemtuzumab ozogamicin 4.5 MG Injection
Term type: SCD
Status: DailyMed mapping
Updated: 2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761060	Mylotarg	gemtuzumab ozogamicin	351(a)	Rx	2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
Mylotarg	GEMTUZUMAB OZOGAMICIN	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	32fd2bb2-1cfa-4250-feb8-d7956c794e05	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1944701

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
32fd2bb2-1cfa-4250-feb8-d7956c794e05	gemtuzumab ozogamicin 4.5 MG Injection [PSN] · gemtuzumab ozogamicin 4.5 MG Injection [SCD]	2	19	These highlights do not include all the information needed to use MYLOTARG safely and effectively. See full prescribing information for MYLOTARG. MYLOTARG™ (gemtuzumab ozogamicin) for injection, for intravenous use Initial U.S. Approval: 2000	20251219