Home NDC 0008-0100 Besponsa
Product NDC 0008-0100
11-digit product format 000080100
Labeler code 0008
Product ID 0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name inotuzumab ozogamicin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application BLA761040
Marketing category BLA
Marketing start 2017-08-18
Substance INOTUZUMAB OZOGAMICIN
Active strength .25 mg/mL
Pharmacologic classes CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Besponsa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INOTUZUMAB OZOGAMICIN .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P93RUU11P7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1942954 Internal RxNorm lookup 1942959 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0008-0100-01 Besponsa 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 4 8 0008-0100-01 Besponsa 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0008-0100 BESPONSA (INOTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240918_cc7014b1-c775-411d-b374-8113248b4077.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Besponsa INOTUZUMAB OZOGAMICIN Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. cc7014b1-c775-411d-b374-8113248b4077 2026-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761040 ndc (product): 0008-0100
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761040 Besponsa inotuzumab ozogamicin 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0008-0100-01 00008010001 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE 2017-08-18 0000-00-00 No No Current