FDA.reportPublic FDA data

POTELIGEO

Product NDC
42747-761
11-digit product format
427470761
Labeler code
42747
Product ID
42747-761_2002b8eb-c6a6-4f3f-8a58-963fe6c015c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mogamulizumab-kpkc
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Kyowa Kirin, Inc.
Application
BLA761051
Marketing category
BLA
Marketing start
2018-08-08
Substance
MOGAMULIZUMAB
Active strength
4 mg/mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Chemokine Receptor Type 4 Interaction [EPC], Chemokine Receptor Type 4 Interactions [MoA], Monoclonal Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POTELIGEO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOGAMULIZUMAB4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYI437801BE
Rxcui2054081, 2054086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ab7dcf8f-0c3b-4681-a4b5-7f9aea69c0e0Product name120181016
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42747-761-01POTELIGEO1 in 1 CARTONINJECTION120
42747-761-01POTELIGEO5 mL in 1 VIAL, GLASSINJECTION520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42747-761-01ML - Milliliter42747-761a996a146-f4b2-4c03-9616-8cd1b3774ae512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42747-761POTELIGEO (MOGAMULIZUMAB-KPKC) INJECTION [KYOWA KIRIN, INC.]18Current NDC, Legacy NDC, 2 package rows20250508_e53960ab-42a1-40d1-9c7d-eb013fe7f18f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054081mogamulizumab-kpkc 20 MG in 5 ML InjectionPSNe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
2054086POTELIGEO 20 MG in 5 ML InjectionPSNe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
20540865 ML mogamulizumab-kpkc 4 MG/ML Injection [Poteligeo]SBDe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
20540815 ML mogamulizumab-kpkc 4 MG/ML InjectionSCDe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
20540865 ML Poteligeo 4 MG/ML InjectionSYe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
2054081mogamulizumab-kpkc 20 MG per 5 ML InjectionSYe53960ab-42a1-40d1-9c7d-eb013fe7f18f20
2054086Poteligeo 20 MG per 5 ML InjectionSYe53960ab-42a1-40d1-9c7d-eb013fe7f18f20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42747-761-01427470761011 VIAL, GLASS in 1 CARTON (42747-761-01) / 5 mL in 1 VIAL, GLASS2018-08-080000-00-00NoNoCurrent