Winrho Sdf
NDC Package 49591-300-51
Package Information
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 49591-300 and is authorized under FDA application BLA103649.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 49591 - Kamada Ltd.
- 49591-300 - Winrho Sdf
- 49591-300-51 - 1 VIAL, GLASS in 1 CARTON / 13 mL in 1 VIAL, GLASS (49591-300-13)
- 49591-300 - Winrho Sdf
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.
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 49591-300-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 13 ml in 1 vial, glass (49591-300-13) 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 January 31, 2026.
How is this Kamada Ltd. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 49591030051. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
