FDA.reportPublic FDA data

Jemperli

Product NDC
0173-0898
11-digit product format
001730898
Labeler code
0173
Product ID
0173-0898_da2ad681-d178-42c9-aa55-47c619cc7cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dostarlimab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GlaxoSmithKline LLC
Application
BLA761174
Marketing category
BLA
Marketing start
2021-04-22
Substance
DOSTARLIMAB
Active strength
50 mg/mL
Pharmacologic classes
Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOSTARLIMAB50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P0GVQ9A4S5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2539972Internal RxNorm lookup
2539977Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
095eab9f-545a-4f12-bfb7-19477fb901a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
07022db5-0b52-404d-b8c4-114ccd0cdde9Product name120211019
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0898-03Jemperli10 mL in 1 VIALINJECTION1014
0173-0898-03Jemperli1 in 1 CARTONINJECTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0898-03ML - Milliliter0173-089891125878-4119-49bb-9ca8-74086bebb81d12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0898JEMPERLI (DOSTARLIMAB) INJECTION [GLAXOSMITHKLINE LLC]11Current NDC, Legacy NDC, 2 package rows20250504_095eab9f-545a-4f12-bfb7-19477fb901a5.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
JemperliDOSTARLIMABGlaxoSmithKline LLC095eab9f-545a-4f12-bfb7-19477fb901a52025-09-02Warnings, Adverse reactionsExact identifier
application number: BLA761174
ndc (product): 0173-0898

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761174Jemperlidostarlimab-gxly351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2539972dostarlimab-gxly 500 MG in 10 mL InjectionPSN095eab9f-545a-4f12-bfb7-19477fb901a514
2539977Jemperli 500 MG in 10 mL InjectionPSN095eab9f-545a-4f12-bfb7-19477fb901a514
253997710 ML dostarlimab-gxly 50 MG/ML Injection [Jemperli]SBD095eab9f-545a-4f12-bfb7-19477fb901a514
253997210 ML dostarlimab-gxly 50 MG/ML InjectionSCD095eab9f-545a-4f12-bfb7-19477fb901a514
253997710 ML Jemperli 50 MG/ML InjectionSY095eab9f-545a-4f12-bfb7-19477fb901a514
2539972dostarlimab-gxly 500 MG per 10 ML InjectionSY095eab9f-545a-4f12-bfb7-19477fb901a514
2539977Jemperli 500 MG per 10 ML InjectionSY095eab9f-545a-4f12-bfb7-19477fb901a514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0898-03001730898031 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIAL1 vial2021-04-220000-00-00NoNoCurrent