Prescription drug · BLA
Penpulimab kcqx (Penpulimab) NDC 83654-105
Penpulimab 100 mg/10mL · Injection · Intravenous · Akeso Biopharma, Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83654-105-01 | 83654010501 | 1 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 23, 2025 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Penpulimab kcqxSuffix: kcqx
- Generic name (nonproprietary)
- penpulimab
- Active ingredients
- Penpulimab — 100 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Akeso Biopharma, Co., LtdNDC labeler code 83654
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761258
- Marketing start
- Listing expires
- Identifiers
- Product ID 83654-105_5af2c808-a2ec-623f-e063-6294a90a6d99SPL ID 5af2c808-a2ec-623f-e063-6294a90a6d99SPL set ID 830004e8-31af-4cc6-ab16-e870cab1c5caRxCUI 2712652UNII IBS1BZ4E4I
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
N483654010501followed by a unit qualifier and the quantityPackage 83654-0105-01. 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)
Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment…
Excerpt only. Read the full label for complete information.
About NDC 83654-105
- What is NDC 83654-105?
- 83654-105 is the product NDC for Penpulimab kcqx (penpulimab), Penpulimab 100 mg/10mL injection, listed with the FDA by Akeso Biopharma, Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Penpulimab kcqx (Penpulimab).
- What is the active ingredient?
- Penpulimab.
- Who is the labeler?
- Akeso Biopharma, Co., Ltd, NDC labeler code 83654. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Penpulimab kcqx?
- 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.