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NDC 00173-0898-03 Jemperli 50 mg/mL Details
Jemperli 50 mg/mL
Jemperli is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GlaxoSmithKline LLC. The primary component is DOSTARLIMAB.
MedlinePlus Drug Summary
Dostarlimab-gxly injection is used to treat a certain type of endometrial cancer (cancer that begins in the lining of the uterus) in adults that has progressed or has returned after treatment with other chemotherapy medication(s). Dostarlimab-gxly injection is also used to treat a certain type of solid tumor that has spread to other parts of the body in adults who were previously treated unsuccessfully with another chemotherapy medication and do not have other satisfactory treatment options. Dostarlimab-gxly injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the person's immune system to fight against the cancer cells, and helps to slow tumor growth.
Related Packages: 00173-0898-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dostarlimab-gxly Injection
Product Information
| NDC | 00173-0898 |
|---|---|
| Product ID | 0173-0898_e98f1917-0956-4ed1-a7f5-30774d27ea8c |
| Associated GPIs | 21357928302020 |
| GCN Sequence Number | 082209 |
| GCN Sequence Number Description | dostarlimab-gxly VIAL 500MG/10ML INTRAVEN |
| HIC3 | V3R |
| HIC3 Description | ANTINEOPLASTIC,ANTI-PROGRAMMED DEATH-1 (PD-1) MAB |
| GCN | 49556 |
| HICL Sequence Number | 047318 |
| HICL Sequence Number Description | DOSTARLIMAB-GXLY |
| Brand/Generic | Brand |
| Proprietary Name | Jemperli |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dostarlimab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | DOSTARLIMAB |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761174 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00173-0898-03 (00173089803)
| NDC Package Code | 0173-0898-03 |
|---|---|
| Billing NDC | 00173089803 |
| Package | 1 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIAL |
| Marketing Start Date | 2021-04-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |