NDC 0008-4510

Mylotarg

Gemtuzumab Ozogamicin

Mylotarg is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Gemtuzumab Ozogamicin.

• Product ID: 0008-4510_091bfc51-844b-478e-8628-10c00ef7c5b8
• NDC: 0008-4510
• Product Type: Human Prescription Drug
• Proprietary Name: Mylotarg
• Generic Name: Gemtuzumab Ozogamicin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-09-07
• Marketing Category: BLA / BLA
• Application Number: BLA761060
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: GEMTUZUMAB OZOGAMICIN
• Active Ingredient Strength: 5 mg/5mL
• Pharm Classes: CD33-directed Immunoconjugate [EPC],CD33-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0008-4510-01

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

• Marketing Start Date: 2017-09-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-4510-01 [00008451001]

Mylotarg INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761060
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-07

Drug Details

Active Ingredients

Ingredient	Strength
GEMTUZUMAB OZOGAMICIN	5 mg/5mL

OpenFDA Data

• SPL SET ID: 32fd2bb2-1cfa-4250-feb8-d7956c794e05
• Manufacturer:
  • Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
• UNII:
  • 8GZG754X6M
• RxNorm Concept Unique ID - RxCUI:
  • 1944704
  • 1944701

Pharmacological Class

• CD33-directed Immunoconjugate [EPC]
• CD33-directed Antibody Interactions [MoA]