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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YI437801BEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2054081Internal RxNorm lookup
2054086Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e53960ab-42a1-40d1-9c7d-eb013fe7f18fAvailable on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTELIGEOMOGAMULIZUMAB-KPKCKyowa Kirin, Inc.e53960ab-42a1-40d1-9c7d-eb013fe7f18f2026-03-02Warnings, Adverse reactionsExact identifier
application number: BLA761051
ndc (product): 42747-761

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761051Poteligeomogamulizumab-kpkc351(a)Rx2026-07-01

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