NDC 0008-0100

Besponsa

Inotuzumab Ozogamicin

Besponsa 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 Inotuzumab Ozogamicin.

• Product ID: 0008-0100_46f22997-83ff-4ff3-bc6b-263767c792dc
• NDC: 0008-0100
• Product Type: Human Prescription Drug
• Proprietary Name: Besponsa
• Generic Name: Inotuzumab Ozogamicin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-08-18
• Marketing Category: BLA / BLA
• Application Number: BLA761040
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: INOTUZUMAB OZOGAMICIN
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: CD22-directed Immunoconjugate [EPC],CD22-directed Antibody Interactions [MoA],Decreased DNA Integrity [PE],Increased Cellular Death [PE],Immunoconjugates [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0008-0100-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) > 4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-0100-01 [00008010001]

Besponsa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761040
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-18

Drug Details

Active Ingredients

Ingredient	Strength
INOTUZUMAB OZOGAMICIN	.25 mg/mL

OpenFDA Data

• SPL SET ID: cc7014b1-c775-411d-b374-8113248b4077
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • P93RUU11P7
• RxNorm Concept Unique ID - RxCUI:
  • 1942959
  • 1942954

Pharmacological Class

• CD22-directed Immunoconjugate [EPC]
• CD22-directed Antibody Interactions [MoA]
• Decreased DNA Integrity [PE]
• Increased Cellular Death [PE]
• Immunoconjugates [CS]
• CD22-directed Immunoconjugate [EPC]
• CD22-directed Antibody Interactions [MoA]
• Decreased DNA Integrity [PE]
• Increased Cellular Death [PE]
• Immunoconjugates [CS]