Jemperli
- Product NDC
- 0173-0898
- Requested package NDC
- 0173-0898-03
- 11-digit product format
- 001730898
- Labeler code
- 0173
- Product ID
- 0173-0898_ef9919b1-7a29-45a6-ab69-7aa30ac9bff9
- 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
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
- Jemperli
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOSTARLIMAB | 50 mg/mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| P0GVQ9A4S5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 2539972 | Internal RxNorm lookup |
| 2539977 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0173-0898-03 | Jemperli | 10 mL in 1 VIAL | INJECTION | 10 | | 14 |
| 0173-0898-03 | Jemperli | 1 in 1 CARTON | INJECTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0173-0898 | JEMPERLI (DOSTARLIMAB) INJECTION [GLAXOSMITHKLINE LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250504_095eab9f-545a-4f12-bfb7-19477fb901a5.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761174 | Jemperli | dostarlimab-gxly | 351(a) | Rx | 2026-10-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0173-0898-03 | 00173089803 | 1 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIAL | 1 vial | 2021-04-22 | 0000-00-00 | No | No | Current |