Prescription drug · BLA
Keytruda Qlex NDC 0006-5083
pembrolizumab and berahyaluronidase alfa-pmph · Pembrolizumab 165 mg/mL; Berahyaluronidase alfa 2000 U/mL · Injection, Solution · Subcutaneous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5083-01 | 00006508301 | 1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99)Marketed from Sep 19, 2025 |
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)
- Keytruda Qlex
- Generic name (nonproprietary)
- pembrolizumab and berahyaluronidase alfa-pmph
- Active ingredients
- Pembrolizumab — 165 mg/mLBerahyaluronidase alfa — 2000 U/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761467
- Marketing start
- Listing expires
- Other FDA classes
- Glycoside Hydrolases (Chemical structure)Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0006-5083_18b3adae-863b-413b-8e36-e3551115db37SPL ID 18b3adae-863b-413b-8e36-e3551115db37SPL set ID 097d166f-b73b-41d3-9b37-7653cd2a0c41RxCUI 2723762, 2723769, 2723771, 2723772UNII DPT0O3T46P, 9X4R4A4HQQ
- Pharmacologic class
- Endoglycosidase; 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
N400006508301followed by a unit qualifier and the quantityPackage 00006-5083-01. 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)
KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclit…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761467
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Keytruda Qlexpembrolizumab and berahyaluronidase alfa-pmph | Pembrolizumab 165 mg/mL; Berahyaluronidase alfa 2000 U/mL | Injection, SolutionSubcutaneous | Merck Sharp & Dohme LLC | 0006-3083 |