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Penpulimab kcqx 100 mg/10mL Injection — NDC 83654-0105-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Penpulimab kcqx 100 mg/10mL Injection — NDC 83654-105-01 (Billing 83654-0105-01) · Product 83654-105

by Akeso Biopharma, Co., Ltd · 1 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSE

NDC 83654-105-01 (billing 83654-0105-01) is a package of Penpulimab kcqx 100 mg/10mL Injection from Akeso Biopharma, Co., Ltd, marketed since Apr 2025 and currently FDA-listed. It is the main listing for product NDC 83654-105, its only package size.

NDC 83654-0105-01
🏷️ FDA NDC (as labeled) 83654-105-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83654-105-01
Product NDC 83654-105
11-digit billing NDC 83654010501
RxCUI 2712652
UNII IBS1BZ4E4I
Application # BLA761258
SPL Set ID 830004e8-31af-4cc6-ab16-e870cab1c5ca
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-23
Route INTRAVENOUS
Dosage form INJECTION
Substance PENPULIMAB
Biologic (Purple Book) 351(a)
Quick answers for NDC 83654-105-01
  • RxCUI (RxNorm): 2712652
  • 11-digit billing NDC: 83654010501
Why two NDCs? The FDA registers this code as 83654-105-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83654-0105-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📖 What it is MedlinePlus · NLM

Penpulimab-kcqx injection is used for treatment of certain types of nasopharyngeal cancer (cancer in the upper part of the throat). Penpulimab-kcqx is in a class of medications called monoclonal antibodies. It works by helping the immune system attack the cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats adults with non-keratinizing nasopharyngeal carcinoma, a cancer of the upper throat. It is used with chemotherapy as first treatment when the cancer has come back or spre...
  • It is given as an IV infusion over about 60 minutes by your care team. The schedule is every 3 weeks with chemotherapy or every 2 weeks alone, for up to 24 months. They will tell y...
  • Nausea, vomiting, tiredness, constipation, low appetite, rash and an underactive thyroid are common. Anemia is also common when used alone. Tell your team about any new symptom so...
  • Call for new cough or breathing trouble, diarrhea, yellow skin or eyes, severe rash, intense tiredness, or high blood sugar signs like extreme thirst. These can signal immune react...
📖 Read our full Penpulimab guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83654-0105-01 83654-105-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSE Sample 2025-04-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Penpulimab kcqx 100 mg/10mLthis 83654-0105-01 Akeso 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 23, 2025 ⏳ ~10.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
penpulimab-kcqx
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateApr 23, 2037
Common questions
Is there a biosimilar for this drug?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.9 mg / 10 mL UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 2 mg / 10 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 25.2 mg / 10 mL UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • 450 mg / 10 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAkeso Biopharma, Co., Ltd
FDA applicationBLA761258 (BLA)
Labeler code83654
First marketedApr 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 147 words ▾

1 INDICATIONS AND USAGE 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 )

1.1First-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 of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

1.2Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, as a single agent, is indicated for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine: 200 mg intravenously over 60 minutes every 3 weeks until disease progression or a maximum of 24 months. ( 2.1 ) Penpulimab-kcqx as a single agent: 200 mg intravenously over 60 minutes every 2 weeks until disease progression or a maximum of 24 months. ( 2.2 ) Dilute prior to administration. ( 2.4 )

2.1Recommended Dosage of Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine – Every 3 Week Dosing First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma The recommended dosage of penpulimab-kcqx is 200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. Table 1 Order of Administration and Regimen for Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine Administer the regimen in the following order: penpulimab-kcqx first, gemcitabine second and cisplatin or carboplatin last.

Drug and Dose Duration/ Timing of Treatment penpulimab-kcqx 200 mg intravenously Every 3 weeks for 6 cycles, and then every 3 weeks until unacceptable toxicity or disease progression for a maximum of 24 months gemcitabine 1000 mg/m 2 intravenously Every 3 weeks for 6 cycles cisplatin 80 mg/m 2 intravenously or carboplatin AUC 5 intravenously Every 3 weeks for 6 cycles

2.2Recommended Dosage of Penpulimab-kcqx as a Single Agent – Every 2 Week Dosing Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma The recommended dosage of penpulimab-kcqx is 200 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity, for a maximum of 24 months.

2.3Dosage Modifications of Penpulimab-kcqx for Adverse Reactions No dose reduction for penpulimab-kcqx is recommended. In general, withhold penpulimab-kcqx for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue penpulimab-kcqx for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for penpulimab-kcqx in combination or penpulimab-kcqx as a single agent for adverse reactions that require management different from these general guidelines are summarized in Table 2 . Table 2 Recommended Dosage Modification for Adverse Reactions Adverse Reaction Severity* Dosage Modification Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold † Grade 3 or 4 Permanently discontinue Colitis Grade 2 or 3 Withhold † Grade 4 Permanently discontinue Hepatitis with no tumor involvement of the liver AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN Withhold † AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Hepatitis with tumor involvement of the liver ‡ Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN Withhold † ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Endocrinopathies Grade 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity Nephritis with Renal Dysfunction Grade 2 or 3 increased blood creatinine Withhold † Grade 4 increased blood creatinine Permanently discontinue Exfoliative Dermatologic Conditions Suspected SJS, TEN, or DRESS Withhold † Confirmed SJS, TEN, or DRESS Permanently discontinue Myocarditis Grade 2, 3, or… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/10 mL (10 mg/mL) as a clear to slightly opalescent, colorless to yellowish solution in a single-dose vial. Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.( 3 )

⛔ Contraindications 6 words ▾

4 CONTRAINDICATIONS None. None.( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, immune-mediated dermatologic adverse reactions and solid organ transplant rejection. o Monitor for early identification and management.

Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue penpulimab-kcqx based on severity and type of reaction. Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue penpulimab-kcqx based on the severity of the reaction. ( 5.2 ) Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 )

5.1Severe and Fatal Immune-Mediated Adverse Reactions Penpulimab-kcqx is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under WARNINGS AND PRECAUTIONS may not include all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD- L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.

Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.

In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue penpulimab-kcqx depending on severity [see Dosage and Administration (2) ] .

In general, if penpulimab-kcqx requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month [ see Dosage and A dministration (2) ] . Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis Penpulimab-kcqx can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

Penpuli… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in other sections of the labeling: Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions[see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine : The most common adverse reactions (≥20%) were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia.

( 6.1 ) Penpulimab-kcqx as a single agent : The most common adverse reactions (≥20%) were anemia and hypothyroidism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Akeso Biopharma Co., Ltd. at toll-free phone 833-662-5376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to those observed in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS reflect exposure to penpulimab-kcqx in 146 patients in Study AK105-304 [see Clinical Studies (14.1) ] . Patients received 6 cycles every 3 weeks of intravenous penpulimab-kcqx 200 mg in combination with either cisplatin 80 mg/m 2 or carboplatin AUC 5 and gemcitabine 1000 mg/m 2 followed by single-agent penpulimab-kcqx 200 mg every 3 weeks until disease progression or a maximum of 24 months.

Among the 146 patients who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine, 71% were exposed for 6 months or longer and 38% were exposed for greater than one year. In this safety population, the most common (≥ 20%) adverse reactions were nausea (58%), vomiting (55%), hypothyroidism (45%), constipation (41%), decreased appetite (36%), decreased weight (26%), cough (25%), COVID-19 infection (25%), fatigue (25%), rash (24%) and pyrexia (21%). The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes (70%), decreased neutrophils (61%), decreased white blood cells (58%), decreased hemoglobin (49%), decreased platelets (33%), decreased potassium (14%), increased lipase (11%), increased ALT (8%), decreased sodium (7%), increased AST (6%), increased triglycerides (4.3%), decreased magnesium (4.2%), decreased CPK (4.1%), increased amylase (2.9%), increased potassium (2.8%), increased cholesterol (2.2%), increased calcium (2.1%) and increased blood bilirubin (2.1%).

The data described in the WARNINGS AND PRECAUTIONS also reflect exposure to single-agent intravenous penpulimab-kcqx 200 mg every 2 weeks until disease progression or a maximum of 24 months in 372 patients in studies: AK105-101 [NCT03352531], AK-105-201 [NCT03722147], AK105-202 [see Clinical Studies (14.2)] , AK105-204 [NCT 04172506]. Among the 372 patients who received single-agent penpulimab-kcqx, 49% were exposed for 6 months or longer and 34% were exposed for at least one year. In this safety population, the most common (≥20%) adverse reactions were anemia (25%) and hypothyroidism (23%).

The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes (11%), increased GGT (9%), decreased phosphate (6%), decreased sodium (4.7%), increased aspartate aminotransferase (4.4%), increased alkaline phosphatase (4%), decreased hemoglobin (3.6%), increased bilirubin (2.7%), increased glucose (3%), increased triglycerides (2.8%), increased alanine aminotransferase (2.5%), increased magnesium (3.3%), and decreased platelets (2.5%). First line Recurrent or Metastatic Nasopharyngeal Carcinoma Study AK105-304 The safety of penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 [see Clinical Studies (14.1) ] .

Patients received intravenous p… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

8.1Pregnancy Risk Summary Based on its mechanism of action, penpulimab-kcqx can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of penpulimab-kcqx in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death ( see Data ).

Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, penpulimab-kcqx has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Animal reproduction studies have not been conducted with penpulimab-kcqx to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering penpulimab-kcqx during pregnancy include increased rates of abortion or stillbirth.

As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to penpulimab-kcqx may increase the risk of developing immune-mediated disorders or of altering the normal immune response.

8.2Lactation Risk Summary There is no information regarding the presence of penpulimab-kcqx in human milk or its effects on the breastfed child, or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to penpulimab-kcqx are unknown.

Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for 4 months after the last dose of penpulimab-kcqx.

8.3Females and Males of Reproductive Potential Penpulimab-kcqx can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating penpulimab-kcqx [see Use in Specific Populations (8.1) ]. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with penpulimab-kcqx and for 4 months after the last dose.

8.4Pediatric Use The safety and effectiveness of penpulimab-kcqx have not been established in pediatric patients [see Indications and Usage (1)] .

8.5Geriatric Use Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine Of the 146 patients with NPC who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine, 15 (10%) were 65 years or older and 1 (0.7%) was 75 years or older. Clinical studies did not include a sufficient number of patients aged 65 years or older to determine differences in safety or effectiveness compared to younger patients [see Adverse Reactions (6) ]. Penpulimab-kcqx as a Single-Agent Of the 372 patients with NPC who received penpulimab-kcqx as a single agent, 69 (19%) were 65 years or older and 7% were 75 years and older.

No overall differences in safety or effectiveness were observed between patients age <65 and those ≥ 65 years [see Adverse Reactions (6) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Penpulimab-kcqx injection is a humanized IgG1 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

In murine tumor models, blocking PD-1 activity resulted in decreased tumor growth.

12.2Pharmacodynamics Penpulimab-kcqx exposure-response relationships and the time course of pharmacodynamic response are not fully characterized.

12.3Pharmacokinetics Penpulimab-kcqx exposure increased dose proportionally over the dose range of 1 to 10 mg/kg (0.35 to 3.5 times the approved recommended dosage in a 70 kg patient) after the first dose. The mean accumulation ratio was 1.5 for maximum concentration (C max ) and 2.1 for area under the concentration curve (AUC) following multiple doses of 200 mg every 3 weeks. Steady-state concentrations of penpulimab-kcqx were reached by Week 15, with mean (CV%) steady-state trough and peak concentrations of 30 μg/mL (38%) and 88 μg/mL (21%), respectively.

Distribution The mean (CV%) volume of distribution was 10 L (44%). Elimination The mean (CV%) clearance was

0.2L/day (33%) and the mean (CV%) terminal half-life was 32 days (44%). Metabolism Penpulimab-kcqx is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of penpulimab-kcqx were observed based on body weight (32 to 113 kg), age (18 to 91 years), sex, race (White and Asian), serum albumin (22 to 54.5 g/L), baseline LDH (111 to 4,450 IU/L), baseline C-reactive protein (0 to 328 mg/L), baseline ECOG score (0 and 1), immunogenicity status, tumor type (NPC and other tumors), co-administration (with chemotherapy), mild or moderate renal impairment (creatinine clearance [CLcr] ≥ 30 mL/min), mild (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1 to 1.5 times ULN and any AST) or moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN and any AST).

The effect of severe hepatic (total bilirubin > 3 times ULN and any AST) or renal impairment (CLcr < 30 mL/min) on the pharmacokinetics of penpulimab-kcqx is unknown.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of penpulimab-kcqx or of other penpulimab products. Of the 349 evaluable patients who received penpulimab-kcqx 1, 3, 10 mg/kg every two weeks or 200 mg every two weeks or every three weeks as a single agent, 30% (105/349) of patients tested positive for anti-drug antibodies (ADA) at one or more post-baseline timepoints.

Of those who tested positive for ADA, 17% (18/105) had neutralizing antibodies against penpulimab-kcqx. Of the 371 evaluable patients who received penpulimab-kcqx 200 mg every 3 weeks in combination with chemotherapy, 24% (88/371) of patients tested positive for ADA at one or more post-baseline timepoints. Of those who tested positive for ADA, 44% (39/88) had neutralizing antibodies against penpulimab-kcqx.

There are insufficient data to assess whether the observed anti-penpulimab-kcqx antibodies affect the safety or effectiveness of penpulimab-kcqx.

🧬 Mechanism of Action 95 words ▾

12.1Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Penpulimab-kcqx injection is a humanized IgG1 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

In murine tumor models, blocking PD-1 activity resulted in decreased tumor growth.

📦 How Supplied / Storage and Handling 61 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Penpulimab-kcqx injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellowish solution supplied as: Carton containing one 100 mg/10 mL (10 mg/mL) single-dose vial NDC 83654-105-01 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake. Do not freeze.

📋 Description 100 words ▾

11 DESCRIPTION Penpulimab-kcqx is a programmed death receptor-1 (PD 1)-blocking antibody. Penpulimab-kcqx is a humanized monoclonal IgG1 antibody with an approximate molecular weight of 150 kDa. Penpulimab-kcqx is produced in Chinese hamster ovary (CHO) cells.

Penpulimab-kcqx injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellowish solution for intravenous infusion after dilution. Each vial contains 100 mg of penpulimab-kcqx in 10 mL solution. Each mL of solution contains: penpulimab-kcqx 10 mg, acetic acid (0.09 mg), polysorbate 80 (0.2 mg), sodium acetate (2.52 mg), sorbitol (45 mg), and Water for Injection, USP.

The pH of the solution is 5.8.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE PENPULIMAB-KCQX (pen pul i mab kcqx) injection What is the most important information I should know about penpulimab-kcqx? Penpulimab-kcqx is a medicine that may treat non-keratinizing nasopharyngeal cancer by working with your immune system. Penpulimab-kcqx can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes dark urine (tea colored) severe nausea or vomiting bleeding or bruising more easily than normal pain on the right side of your stomach-area (abdomen) Hormone gland problems headaches that will not go away or unusual headaches urinating more often than usual eye sensitivity to light hair loss eye problems feeling cold rapid heartbeat constipation increased sweating your voice gets deeper extreme tiredness dizziness or fainting weight gain or weight loss changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness feeling more hungry or thirsty than usual Kidney problems decrease in your amount of urine swelling of your ankles blood in your urine loss of appetite Skin problems rash painful sores or ulcers in your mouth or nose, throat, or genital area itching fever or flu-like symptoms skin blistering or peeling swollen lymph nodes Problems can also happen in other organs and tissues.

These are not all of the signs and symptoms of immune system problems that can happen with penpulimab-kcqx. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening .

Signs and symptoms of infusion reactions may include: chills or shaking dizziness itching or rash feeling like passing out flushing fever shortness of breath or wheezing back pain Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with penpulimab-kcqx. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check for these problems during treatment with penpulimab-kcqx. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines.

Your healthcare provider may also need to delay or completely stop treatment with penpulimab-kcqx if you have severe side effects. What is penpulimab-kcqx? Penpulimab-kcqx is a prescription medicine used to treat adults with a kind of cancer cal… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Penpulimab-kcqx exposure increased dose proportionally over the dose range of 1 to 10 mg/kg (0.35 to 3.5 times the approved recommended dosage in a 70 kg patient) after the first dose. The mean accumulation ratio was 1.5 for maximum concentration (C max ) and 2.1 for area under the concentration curve (AUC) following multiple doses of 200 mg every 3 weeks. Steady-state concentrations of penpulimab-kcqx were reached by Week 15, with mean (CV%) steady-state trough and peak concentrations of 30 μg/mL (38%) and 88 μg/mL (21%), respectively.

Distribution The mean (CV%) volume of distribution was 10 L (44%). Elimination The mean (CV%) clearance was

0.2L/day (33%) and the mean (CV%) terminal half-life was 32 days (44%). Metabolism Penpulimab-kcqx is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of penpulimab-kcqx were observed based on body weight (32 to 113 kg), age (18 to 91 years), sex, race (White and Asian), serum albumin (22 to 54.5 g/L), baseline LDH (111 to 4,450 IU/L), baseline C-reactive protein (0 to 328 mg/L), baseline ECOG score (0 and 1), immunogenicity status, tumor type (NPC and other tumors), co-administration (with chemotherapy), mild or moderate renal impairment (creatinine clearance [CLcr] ≥ 30 mL/min), mild (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1 to 1.5 times ULN and any AST) or moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN and any AST).

The effect of severe hepatic (total bilirubin > 3 times ULN and any AST) or renal impairment (CLcr < 30 mL/min) on the pharmacokinetics of penpulimab-kcqx is unknown.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma The efficacy of penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial. The trial included a total of 291 patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). Eligible patients were required to have recurrent NPC with local-regional recurrence and/or distant metastasis occurring ≥ 6 months after completion of curative intent treatment or to have primary metastatic NPC not suitable for local therapy at the time of diagnosis.

Patients with autoimmune disease, other than stable hypothyroidism or Type I diabetes, and patients who required systemic immunosuppression were ineligible. Patients were randomized (1:1) to receive either: Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine, every 3 weeks, for up to 6 cycles, followed by single-agent penpulimab-kcqx every 3 weeks until disease progression or unacceptable toxicity or a maximum of 24 months. Placebo in combination with either cisplatin or carboplatin and gemcitabine, every 3 weeks for up to 6 cycles, followed by single-agent placebo every 3 weeks until disease progression or unacceptable toxicity or a maximum of 24 months.

All study medications were administered intravenously. Randomization was stratified by stage of disease (primary metastatic vs. recurrent), Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1), and liver metastasis (present vs. absent).

Patients randomized to placebo were eligible to receive open-label single-agent penpulimab-kcqx (200 mg every 3 weeks) after radiographic disease progression confirmed by blinded independent central review (BICR). Tumor assessments were performed every 6 weeks for the first 12 months and every 9 weeks thereafter. The major efficacy outcome measure was BICR-assessed progression-free survival (PFS) according to RECIST v1.1.

The key secondary efficacy outcome measure was overall survival (OS). The study population characteristics were: median age of 51 years (range: 23 to 75), 82% male, 98% Asian, 2.1% White; 1.4% Hispanic or Latino; and 36% ECOG PS of 0. At study entry, 80% of patients had metastatic disease.

Histological subtypes of NPC included 96% non-keratinizing, 0.7% keratinizing squamous cell carcinoma, and 3.4% did not have the subtype identified. In total, 98% received cisplatin and 2.4% received carboplatin. Efficacy results of the analysis of PFS are summarized in Table 7 and Figure 1 below.

The trial demonstrated statistically significant improvements in BICR-assessed PFS for patients randomized to penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine compared to placebo with either cisplatin or carboplatin and gemcitabine. OS results were not mature with 70% of pre-specified OS events observed in the overall population. Table 7 Efficacy Results in AK105-304 Endpoint Penpulimab-kcqx cisplatin or carboplatin and gemcitabine N=144 Placebo cisplatin or carboplatin and gemcitabine N=147 BICR-assessed Progression-free Survival Number of Events n (%) 80 (56) 109 (74) Median, months (95% CI) 9.6 (7.1, 12.5) 7.0 (6.9, 7.3) Hazard Ratio (95% CI) † 0.45 (0.33, 0.62) p-value ‡ <0.0001 † Based on a stratified Cox proportional hazard model. ‡ Two-sided p-value, based on the stratified log-rank test, as compared with an alpha boundary of 0.030.

Figure 1 Kaplan-Meier Curves of PFS for AK105-304 Figure 1 Kaplan-Meier Curves of PFS for AK105-304

14.2Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma The efficacy of single-agent penpulimab-kcqx was evaluated in Study AK105-202 (NCT03866967), an open-label, multicenter, single-arm trial conducted in a single country. The trial included a total of 125 patients with unresectable or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) and who had di… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 151 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to assess the potential of penpulimab-kcqx for carcinogenicity or genotoxicity. Fertility studies have not been conducted with penpulimab-kcqx. In 6-week and 3-month repeat dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, most animals in these studies were not sexually mature.

13.2Animal Toxicology and/or Pharmacology In animal models, inhibition of PD-1/PD-L1 signaling increased the severity of some infections and enhanced inflammatory responses. Mycobacterium tuberculosis-infected PD-1 knockout mice exhibit markedly decreased survival compared with wild-type controls, which correlated with increased bacterial proliferation and inflammatory responses in these animals. PD-1 blockade using a primate anti-PD-1 antibody was also shown to exacerbate M. tuberculosis infection in rhesus macaques.

PD-1 and PD-L1 knockout mice and mice receiving PD-L1 blocking antibody have also shown decreased survival following infection with lymphocytic choriomeningitis virus.

📄 Recent Major Changes 8 words ▾

Warnings and Precautions ( 5 ) -------------- 8/2026

📄 Package Label / Principal Display Panel 4 words ▾

carton label vial label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Penpulimab kcqx (this brand).

Top reported reactions

Myelosuppression13
Anaemia12
Hypothyroidism10
Diarrhoea9
Leukopenia9
Rash9
Thrombocytopenia9

Age at onset

Adult12
Elderly4

Reporter sex

70 reports
Male · 67%
Female · 33%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 36 3
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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Orange Book / therapeutic-equivalence data ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83654-105-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83654-0105-01, written without dashes as 83654010501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83654-0105-01, the first segment (83654) is the labeler code FDA assigned to Akeso Biopharma, Co., Ltd; the middle segment (0105) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Akeso Biopharma, Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Akeso Biopharma, Co., Ltd is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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