poteligeo

Generic: mogamulizumab-kpkc

Labeler: kyowa kirin, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name poteligeo
Generic Name mogamulizumab-kpkc
Labeler kyowa kirin, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

mogamulizumab 4 mg/mL

Manufacturer
Kyowa Kirin, Inc.

Identifiers & Regulatory

Product NDC 42747-761
Product ID 42747-761_2002b8eb-c6a6-4f3f-8a58-963fe6c015c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761051
Listing Expiration 2027-12-31
Marketing Start 2018-08-08

Pharmacologic Class

Established (EPC)
chemokine receptor type 4 interaction [epc] monoclonal antibody [epc]
Mechanism of Action
chemokine receptor type 4 interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42747761
Hyphenated Format 42747-761

Supplemental Identifiers

RxCUI
2054081 2054086
UNII
YI437801BE
NUI
N0000193866 N0000193863 N0000193867 M0001357

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 poteligeo (source: ndc)
Generic Name mogamulizumab-kpkc (source: ndc)
Application Number BLA761051 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (42747-761-01) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

42747-761-01 1 VIAL, GLASS in 1 CARTON (42747-761-01) / 5 mL in 1 VIAL, GLASS

Ingredients (1)

mogamulizumab (4 mg/mL)

Linked Drug Pages (1)

POTELIGEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2002b8eb-c6a6-4f3f-8a58-963fe6c015c4", "openfda": {"nui": ["N0000193866", "N0000193863", "N0000193867", "M0001357"], "unii": ["YI437801BE"], "rxcui": ["2054081", "2054086"], "spl_set_id": ["e53960ab-42a1-40d1-9c7d-eb013fe7f18f"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Chemokine Receptor Type 4 Interaction [EPC]", "Monoclonal Antibody [EPC]"], "pharm_class_moa": ["Chemokine Receptor Type 4 Interactions [MoA]"], "manufacturer_name": ["Kyowa Kirin, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (42747-761-01)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "42747-761-01", "marketing_start_date": "20180808"}], "brand_name": "POTELIGEO", "product_id": "42747-761_2002b8eb-c6a6-4f3f-8a58-963fe6c015c4", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Chemokine Receptor Type 4 Interaction [EPC]", "Chemokine Receptor Type 4 Interactions [MoA]", "Monoclonal Antibody [EPC]"], "product_ndc": "42747-761", "generic_name": "mogamulizumab-kpkc", "labeler_name": "Kyowa Kirin, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POTELIGEO", "active_ingredients": [{"name": "MOGAMULIZUMAB", "strength": "4 mg/mL"}], "application_number": "BLA761051", "marketing_category": "BLA", "marketing_start_date": "20180808", "listing_expiration_date": "20271231"}