Prescription drug · BLA
Jemperli (Dostarlimab) NDC 0173-0898
Dostarlimab 50 mg/mL · Injection · Intravenous · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0898-03 | 00173089803 | 1 VIAL in 1 CARTON (0173-0898-03) / 10 mL in 1 VIALMarketed from Apr 22, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Jemperli
- Generic name (nonproprietary)
- dostarlimab
- Active ingredients
- Dostarlimab — 50 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761174
- Marketing start
- Listing expires
- Other FDA classes
- Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0173-0898_da2ad681-d178-42c9-aa55-47c619cc7cb1SPL ID da2ad681-d178-42c9-aa55-47c619cc7cb1SPL set ID 095eab9f-545a-4f12-bfb7-19477fb901a5RxCUI 2539972, 2539977UNII P0GVQ9A4S5
- Pharmacologic class
- Programmed Death Receptor-1 Blocking Antibody
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400173089803followed by a unit qualifier and the quantityPackage 00173-0898-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). ( 1.1 ) • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. ( 1.1 , 2.1 ) Mismatch Repair Deficient Recurrent or Advanced Solid Tumors • as a single a…
Excerpt only. Read the full label for complete information.
About NDC 0173-0898
- What is NDC 0173-0898?
- 0173-0898 is the product NDC for Jemperli (dostarlimab), Dostarlimab 50 mg/mL injection, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jemperli (Dostarlimab).
- What is the active ingredient?
- Dostarlimab.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jemperli?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.