NDC product

Besponsa

NDC 0008-0100 · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Key facts

Product NDC 0008-0100
Proprietary name Besponsa
Nonproprietary name inotuzumab ozogamicin
Substances INOTUZUMAB OZOGAMICIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category BLA
Application number BLA761040
Pharmacologic classes CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]
Marketing start Aug 18, 2017
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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