Rhophylac Solution
NDC Package 44206-300-01

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

Package Information

Rhophylac (human rho(d) immune globulin) solution is rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh0(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh0(D)-positive patients. This formulation utilizes a solution delivery system. Marketed by Csl Behring Ag, this product is identified by NDC 44206-300 and is authorized under FDA application BLA125070.

Identification & Billing

NDC Package Code
44206-300-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS (44206-300-90)
Product Code
44206-300
11-Digit Billing Format
44206030001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1117759 - rho(D) immune globulin, human 1500 UNT in 2 ML Prefilled Syringe
  • RxCUI: 1117759 - 2 ML Rho(D) immune globulin, human 750 UNT/ML Prefilled Syringe
  • RxCUI: 1117759 - rho(D) immune globulin, human 1500 UNT per 2 ML Prefilled Syringe
  • RxCUI: 1117765 - Rhophylac 1500 UNT in 2 ML Prefilled Syringe
  • RxCUI: 1117765 - 2 ML Rho(D) immune globulin, human 750 UNT/ML Prefilled Syringe [Rhophylac]

Clinical Specifications

Proprietary Name
Rhophylac
Non-Proprietary Name
Human Rho(d) Immune Globulin
Substance Name
Human Rho(d) Immune Globulin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/2mL
Pharmacologic Class
Usage Information
Rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh0(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh0(D)-positive patients.

Regulatory & Marketing

Labeler Name
Csl Behring Ag
Product Type
Plasma Derivative
FDA Application #
BLA125070
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-06-2009
Listing Expiration
12-31-2026
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.

J2791
Source: PDAC
INJECTION, RHO(D) IMMUNE GLOBULIN (HUMAN), (RHOPHYLAC), INTRAMUSCULAR OR INTRAVENOUS, 100 IU
HCPCS Dosage 100 IU
Units / Pkg

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (44206-300). Click a package code to view its specific billing and regulatory data.

44206-300-10
10 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS (44206-300-90)

* 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 44206-300-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / 2 ml in 1 syringe, glass (44206-300-90) of Rhophylac, a plasma derivative labeled by Csl Behring Ag. This solution is formulated for intramuscular; intravenous use and contains human rho(d) immune globulin 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 Csl Behring Ag on January 06, 2009. The current certification is valid through December 31, 2026.

How is this Csl Behring Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44206030001. 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)
44206-300-01
11-Digit CMS (5-4-2)
44206-0300-01

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