Drug Information

Product NDC: 0008-0100

Proprietary Name: Besponsa

Non Proprietary Name: inotuzumab ozogamicin

Active Ingredient(s):

Administration Route(s): INTRAVENOUS


Pharmacy Class(es):
  • CD22-directed Antibody Interactions [MoA];
  • CD22-directed Immunoconjugate [EPC];
  • Decreased DNA Integrity [PE];
  • Immunoconjugates [CS];
  • Increased Cellular Death [PE]

Labeler Information

Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
FDA Application Number: BLA761040
Marketing Category: BLA
Start Marketing Date:8/18/2017

Package Information

No. Package Code Package Description Billing Unit
10008-0100-011 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0008-0100The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEBesponsaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEinotuzumab ozogamicinThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/18/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA761040This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEINOTUZUMAB OZOGAMICINAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESCD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE] 

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This page was last updated on: 4/12/2024