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  5. NDC Package Code: 0006-5083-01 Keytruda Qlex

NDC Package 0006-5083-01 Keytruda Qlex

Pembrolizumab And Berahyaluronidase Alfa-pmph Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Keytruda Qlex
Non-Proprietary Name:
Pembrolizumab And Berahyaluronidase Alfa-pmph
Substance Name:
Berahyaluronidase Alfa; Pembrolizumab
Usage Information:
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.
11-Digit NDC Billing Format:
00006508301
Product Type:
Human Prescription Drug
Labeler Name:
Merck Sharp & Dohme Llc
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(s):
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
BLA761467
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
09-19-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 0006-5083-01?

The NDC Packaged Code 0006-5083-01 is assigned to a 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. The product's dosage form is injection, solution and is administered via subcutaneous form.

Is NDC 0006-5083 included in the NDC Directory?

Yes, Keytruda Qlex with product code 0006-5083 is active and included in the NDC Directory. The product was first marketed by Merck Sharp & Dohme Llc on September 19, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0006-5083-01?

The 11-digit format is 00006508301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20006-5083-015-4-200006-5083-01