FDA.reportPublic FDA data

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
IngredientStrength
INOTUZUMAB OZOGAMICIN.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP93RUU11P7
Rxcui1942954, 1942959

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
1b024157-44ac-49c1-84d6-d6fd9bc7af47Product name120171006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-0100-01Besponsa4 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,48
0008-0100-01Besponsa1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-0100-01EA - Each0008-0100b9c12ef4-7b38-4b19-bd29-3b048cc7a79912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-0100BESPONSA (INOTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]6Current NDC, Legacy NDC, 2 package rows20240918_cc7014b1-c775-411d-b374-8113248b4077.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1942959BESPONSA 0.9 MG InjectionPSNcc7014b1-c775-411d-b374-8113248b40778
1942954inotuzumab ozogamicin 0.9 MG InjectionPSNcc7014b1-c775-411d-b374-8113248b40778
1942959inotuzumab ozogamicin 0.9 MG Injection [Besponsa]SBDcc7014b1-c775-411d-b374-8113248b40778
1942954inotuzumab ozogamicin 0.9 MG InjectionSCDcc7014b1-c775-411d-b374-8113248b40778
1942959Besponsa 0.9 MG InjectionSYcc7014b1-c775-411d-b374-8113248b40778

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0008-0100-01000080100011 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE2017-08-180000-00-00NoNoCurrent