Home NDC 0008-4510 Mylotarg
Product NDC 0008-4510
11-digit product format 000084510
Labeler code 0008
Product ID 0008-4510_ef242018-af2a-4c03-99b7-908e2610f86f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemtuzumab ozogamicin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application BLA761060
Marketing category BLA
Marketing start 2017-09-07
Substance GEMTUZUMAB OZOGAMICIN
Active strength 5 mg/5mL
Pharmacologic classes CD33-directed Antibody Interactions [MoA], CD33-directed Immunoconjugate [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Mylotarg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMTUZUMAB OZOGAMICIN 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8GZG754X6M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1944701 Internal RxNorm lookup 1944704 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 0008-4510-01 Mylotarg 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 19 0008-4510-01 Mylotarg 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0008-4510 MYLOTARG (GEMTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250406_32fd2bb2-1cfa-4250-feb8-d7956c794e05.zip
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 application number: BLA761060 ndc (product): 0008-4510
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0008-4510-01 00008451001 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2017-09-07 0000-00-00 No No Current