jemperli

Generic: dostarlimab

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name jemperli
Generic Name dostarlimab
Labeler glaxosmithkline llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dostarlimab 50 mg/mL

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0898
Product ID 0173-0898_ecb4fc05-fc32-4952-a128-fbd459b050e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761174
Listing Expiration 2026-12-31
Marketing Start 2021-04-22

Pharmacologic Class

Established (EPC)
programmed death receptor-1 blocking antibody [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730898
Hyphenated Format 0173-0898

Supplemental Identifiers

RxCUI
2539972 2539977
UNII
P0GVQ9A4S5
NUI
N0000191260 N0000191259

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name jemperli (source: ndc)
Generic Name dostarlimab (source: ndc)
Application Number BLA761174 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0173-0898-03 1 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIAL

Ingredients (1)

dostarlimab (50 mg/mL)

Linked Drug Pages (1)

Jemperli ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ecb4fc05-fc32-4952-a128-fbd459b050e2", "openfda": {"nui": ["N0000191260", "N0000191259"], "unii": ["P0GVQ9A4S5"], "rxcui": ["2539972", "2539977"], "spl_set_id": ["095eab9f-545a-4f12-bfb7-19477fb901a5"], "pharm_class_epc": ["Programmed Death Receptor-1 Blocking Antibody [EPC]"], "pharm_class_moa": ["Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0173-0898-03)  / 10 mL in 1 VIAL", "package_ndc": "0173-0898-03", "marketing_start_date": "20210422"}], "brand_name": "Jemperli", "product_id": "0173-0898_ecb4fc05-fc32-4952-a128-fbd459b050e2", "dosage_form": "INJECTION", "pharm_class": ["Programmed Death Receptor-1 Blocking Antibody [EPC]", "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "product_ndc": "0173-0898", "generic_name": "dostarlimab", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jemperli", "active_ingredients": [{"name": "DOSTARLIMAB", "strength": "50 mg/mL"}], "application_number": "BLA761174", "marketing_category": "BLA", "marketing_start_date": "20210422", "listing_expiration_date": "20261231"}