Keytruda Qlex Injection, Solution
NDC Package 0006-5083-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection is kEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. This formulation utilizes a injection, solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-5083 and is authorized under FDA application BLA761467.

Identification & Billing

NDC Package Code
0006-5083-01
Package Description
1 VIAL in 1 CARTON / 4.8 mL in 1 VIAL (0006-5083-99)
Product Code
0006-5083
11-Digit Billing Format
00006508301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2723762 - pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT in 2.4 ML Injection
  • RxCUI: 2723762 - 2.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection
  • RxCUI: 2723762 - pembrolizumab-pmph 395 MG / berahyaluronidase alfa-pmph 4800 UNT per 2.4 ML Injection
  • RxCUI: 2723769 - Keytruda Qlex 395 MG / 4800 UNT in 2.4 ML Injection
  • RxCUI: 2723769 - 2.4 ML berahyaluronidase alfa-pmph 2000 UNT/ML / pembrolizumab-pmph 165 MG/ML Injection [Keytruda Qlex]

Clinical Specifications

Proprietary Name
Keytruda Qlex
Non-Proprietary Name
Pembrolizumab And Berahyaluronidase Alfa-pmph
Substance Name
Berahyaluronidase Alfa; Pembrolizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761467
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-19-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9277
Source: ASP
Pembrolizumab 1mg berahyalur
HCPCS Dosage 1 MG
Units / Pkg 790

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-5083-01 identifies a specific commercial package of 1 vial in 1 carton / 4.8 ml in 1 vial (0006-5083-99) of Keytruda Qlex, a human prescription drug labeled by Merck Sharp & Dohme Llc. This injection, solution is formulated for subcutaneous use and contains berahyaluronidase alfa; pembrolizumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on September 19, 2025. The current certification is valid through December 31, 2027.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006508301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0006-5083-01
11-Digit CMS (5-4-2)
00006-5083-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.