besponsa

Generic: inotuzumab ozogamicin

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name besponsa
Generic Name inotuzumab ozogamicin
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

inotuzumab ozogamicin .25 mg/mL

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0008-0100
Product ID 0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761040
Listing Expiration 2027-12-31
Marketing Start 2017-08-18

Pharmacologic Class

Established (EPC)
cd22-directed immunoconjugate [epc]
Mechanism of Action
cd22-directed antibody interactions [moa]
Chemical Structure
immunoconjugates [cs]
Physiologic Effect
decreased dna integrity [pe] increased cellular death [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00080100
Hyphenated Format 0008-0100

Supplemental Identifiers

RxCUI
1942954 1942959
UNII
P93RUU11P7
NUI
N0000193617 N0000193616 N0000008576 N0000009176 M0028142

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name besponsa (source: ndc)
Generic Name inotuzumab ozogamicin (source: ndc)
Application Number BLA761040 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

inotuzumab ozogamicin (.25 mg/mL)

Linked Drug Pages (1)

Besponsa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "427d10d2-c29d-4b71-a5fe-c97736d59aa6", "openfda": {"nui": ["N0000193617", "N0000193616", "N0000008576", "N0000009176", "M0028142"], "unii": ["P93RUU11P7"], "rxcui": ["1942954", "1942959"], "spl_set_id": ["cc7014b1-c775-411d-b374-8113248b4077"], "pharm_class_cs": ["Immunoconjugates [CS]"], "pharm_class_pe": ["Decreased DNA Integrity [PE]", "Increased Cellular Death [PE]"], "pharm_class_epc": ["CD22-directed Immunoconjugate [EPC]"], "pharm_class_moa": ["CD22-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0008-0100-01", "marketing_start_date": "20170818"}], "brand_name": "Besponsa", "product_id": "0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["CD22-directed Antibody Interactions [MoA]", "CD22-directed Immunoconjugate [EPC]", "Decreased DNA Integrity [PE]", "Immunoconjugates [CS]", "Increased Cellular Death [PE]"], "product_ndc": "0008-0100", "generic_name": "inotuzumab ozogamicin", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Besponsa", "active_ingredients": [{"name": "INOTUZUMAB OZOGAMICIN", "strength": ".25 mg/mL"}], "application_number": "BLA761040", "marketing_category": "BLA", "marketing_start_date": "20170818", "listing_expiration_date": "20271231"}