Winrho Sdf
NDC Package 49591-310-51

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Winrho Sdf is winRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients. Marketed by Kamada Ltd., this product is identified by NDC 49591-310 and is authorized under FDA application BLA103649.

Identification & Billing

NDC Package Code
49591-310-51
Package Description
1 VIAL, GLASS in 1 CARTON / 4.4 mL in 1 VIAL, GLASS (49591-310-04)
Product Code
49591-310
11-Digit Billing Format
49591031051
RxNorm Crosswalk
  • RxCUI: 1790374 - rho(D) immune globulin, human 2500 UNT in 2.2 ML Injection
  • RxCUI: 1790374 - 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection
  • RxCUI: 1790374 - rho(D) immune globulin, human 2500 UNT per 2.2 ML Injection
  • RxCUI: 1790379 - WinRho 2500 UNT in 2.2 ML Injection
  • RxCUI: 1790379 - 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection [WinRho]

Clinical Specifications

Proprietary Name
Winrho Sdf
Dosage Form
-
Usage Information
WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients.

Regulatory & Marketing

Labeler Name
Kamada Ltd.
FDA Application #
BLA103649
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-01-2023
End Marketing Date
06-01-2025
Listing Expiration
06-01-2025
Exclude Flag
D
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 49591-310-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 4.4 ml in 1 vial, glass (49591-310-04) of Winrho Sdf, labeled by Kamada Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Kamada Ltd. on August 01, 2023. The current certification is valid through June 01, 2025.

How is this Kamada Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49591031051. 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)
49591-310-51
11-Digit CMS (5-4-2)
49591-0310-51

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