FDA.reportPublic FDA data

Penpulimab

Product NDC
83654-105
11-digit product format
836540105
Labeler code
83654
Product ID
83654-105_3392cd59-0d45-e081-e063-6394a90a0353
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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-e870cab1c5ca2025-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761258
ndc (product): 83654-105

Additional Listing Data#

Finished product
Yes
Brand name base
Penpulimab
Brand name suffix
kcqx
Listing expiration
2026-12-31

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761258penpulimab-kcqx351(a)Rx2026-06-01

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