Besremi Injection
NDC Package 73536-500-01

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

Package Information

Besremi (ropeginterferon alfa-2b) injection is bESREMi is indicated for the treatment of adults with polycythemia vera. This formulation utilizes a injection delivery system. Marketed by Pharmaessentia Usa, this product is identified by NDC 73536-500 and is authorized under FDA application BLA761166.

Identification & Billing

NDC Package Code
73536-500-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
73536-500
11-Digit Billing Format
73536050001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2587064 - ropeginterferon alfa-2b-njft 500 MCG in 1 ML Prefilled Syringe
  • RxCUI: 2587064 - 1 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled Syringe
  • RxCUI: 2587064 - ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe
  • RxCUI: 2587070 - BESREMi 500 MCG in 1 ML Prefilled Syringe
  • RxCUI: 2587070 - 1 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled Syringe [Besremi]

Clinical Specifications

Proprietary Name
Besremi
Non-Proprietary Name
Ropeginterferon Alfa-2b
Substance Name
Ropeginterferon Alfa-2b
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ROPEGINTERFERON ALFA-2B 500 ug/mL
Pharmacologic Class
Usage Information
BESREMi is indicated for the treatment of adults with polycythemia vera.

Regulatory & Marketing

Labeler Name
Pharmaessentia Usa
Product Type
Human Prescription Drug
FDA Application #
BLA761166
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-12-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73536-500-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Besremi, a human prescription drug labeled by Pharmaessentia Usa. This injection is formulated for subcutaneous use and contains ropeginterferon alfa-2b 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 Pharmaessentia Usa on November 12, 2021. The current certification is valid through December 31, 2027.

How is this Pharmaessentia Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73536050001. 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 (5-3-2)
73536-500-01
11-Digit CMS (5-4-2)
73536-0500-01

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