FDA.reportPublic FDA data

Penpulimab

Product NDC
83654-105
11-digit product format
836540105
Labeler code
83654
Product ID
83654-105_5af2c808-a2ec-623f-e063-6294a90a6d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penpulimab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akeso Biopharma, Co., Ltd
Application
BLA761258
Marketing category
BLA
Marketing start
2025-04-23
Substance
PENPULIMAB
Active strength
100 mg/10mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Penpulimab
Brand name suffix
kcqx
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENPULIMAB100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IBS1BZ4E4IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2712652Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
830004e8-31af-4cc6-ab16-e870cab1c5caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7eb17750-f7f8-437f-a575-c4f7bc3e358dProduct name120260130
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83654-105-01Penpulimabkcqx10 mL in 1 VIAL, SINGLE-DOSEINJECTION101
83654-105-01Penpulimabkcqx1 in 1 BOXINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83654-105PENPULIMAB KCQX (PENPULIMAB) INJECTION [AKESO BIOPHARMA, CO., LTD]1Current NDC, 2 package rows20250430_830004e8-31af-4cc6-ab16-e870cab1c5ca.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
Penpulimab kcqxPENPULIMABAkeso Biopharma, Co., Ltd830004e8-31af-4cc6-ab16-e870cab1c5ca2026-09-08Warnings, Adverse reactionsExact identifier
application number: BLA761258
ndc (product): 83654-105

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761258penpulimab-kcqx351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712652penpulimab-kcqx 100 MG in 10 ML InjectionPSN830004e8-31af-4cc6-ab16-e870cab1c5ca1
271265210 ML penpulimab-kcqx 10 MG/ML InjectionSCD830004e8-31af-4cc6-ab16-e870cab1c5ca1
2712652penpulimab-kcqx 100 MG per 10 ML InjectionSY830004e8-31af-4cc6-ab16-e870cab1c5ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83654-105-01836540105011 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSE2025-04-23YesNoCurrent