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 Identifiers# Field, Values table Field Values Unii 8GZG754X6M Rxcui 1944701, 1944704
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
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