mylotarg

Generic: gemtuzumab ozogamicin

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name mylotarg
Generic Name gemtuzumab ozogamicin
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemtuzumab ozogamicin 5 mg/5mL

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0008-4510
Product ID 0008-4510_ef242018-af2a-4c03-99b7-908e2610f86f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761060
Listing Expiration 2026-12-31
Marketing Start 2017-09-07

Pharmacologic Class

Established (EPC)
cd33-directed immunoconjugate [epc]
Mechanism of Action
cd33-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00084510
Hyphenated Format 0008-4510

Supplemental Identifiers

RxCUI
1944701 1944704
UNII
8GZG754X6M
NUI
N0000175571 N0000175077

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mylotarg (source: ndc)
Generic Name gemtuzumab ozogamicin (source: ndc)
Application Number BLA761060 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0008-4510-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemtuzumab ozogamicin (5 mg/5mL)

Linked Drug Pages (1)

Mylotarg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ef242018-af2a-4c03-99b7-908e2610f86f", "openfda": {"nui": ["N0000175571", "N0000175077"], "unii": ["8GZG754X6M"], "rxcui": ["1944701", "1944704"], "spl_set_id": ["32fd2bb2-1cfa-4250-feb8-d7956c794e05"], "pharm_class_epc": ["CD33-directed Immunoconjugate [EPC]"], "pharm_class_moa": ["CD33-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0008-4510-01", "marketing_start_date": "20170907"}], "brand_name": "Mylotarg", "product_id": "0008-4510_ef242018-af2a-4c03-99b7-908e2610f86f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["CD33-directed Antibody Interactions [MoA]", "CD33-directed Immunoconjugate [EPC]"], "product_ndc": "0008-4510", "generic_name": "gemtuzumab ozogamicin", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mylotarg", "active_ingredients": [{"name": "GEMTUZUMAB OZOGAMICIN", "strength": "5 mg/5mL"}], "application_number": "BLA761060", "marketing_category": "BLA", "marketing_start_date": "20170907", "listing_expiration_date": "20261231"}