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  5. NDC Package Code: 49591-310-51 Winrho Sdf

NDC Package 49591-310-51 Winrho Sdf

Human Rho(d) Immune Globulin Injection, Solution Intramuscular; Intravenous - 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:
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
Proprietary Name:
Winrho Sdf
Non-Proprietary Name:
Human Rho(d) Immune Globulin
Substance Name:
Human Rho(d) Immune Globulin
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.
11-Digit NDC Billing Format:
49591031051
NDC to 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]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Kamada Ltd.
    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):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • HUMAN RHO(D) IMMUNE GLOBULIN 5000 [iU]/4.4mL
    • Pharmacologic Class(es):
  • Endogenous Antigen Neutralization - [MoA] (Mechanism of Action)
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA103649
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-01-2023
    Listing Expiration Date:
    12-31-2024
    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 49591-310-51?

    The NDC Packaged Code 49591-310-51 is assigned to a package of 1 vial, glass in 1 carton / 4.4 ml in 1 vial, glass (49591-310-04) of Winrho Sdf, a plasma derivative labeled by Kamada Ltd.. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 49591-310 included in the NDC Directory?

    Yes, Winrho Sdf with product code 49591-310 is active and included in the NDC Directory. The product was first marketed by Kamada Ltd. on August 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 49591-310-51?

    The 11-digit format is 49591031051. 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 5-3-2 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
    5-3-249591-310-515-4-249591-0310-51