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  5. NDC Package Code: 0562-7805-25 Rhogam Ultra-filtered Plus

NDC Package 0562-7805-25 Rhogam Ultra-filtered Plus

Human Rho(d) Immune Globulin Injection, Solution Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
0562-7805-25
Package Description:
25 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
Product Code:
0562-7805
Proprietary Name:
Rhogam Ultra-filtered Plus
Non-Proprietary Name:
Human Rho(d) Immune Globulin
Substance Name:
Human Rho(d) Immune Globulin
Usage Information:
IndicationDoseNotesPregnancy and other obstetrical conditions.Postpartum (if the newborn is Rh-positive)RhoGAM(300 μg)(1500 IU)Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage.Administer within 72 hours of delivery.Antepartum:Prophylaxis at 26 to 28 weeks gestation Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells resulting from:Amniocentesis, chorionic villus sampling (CVS) and percutaneous umbilical blood sampling (PUBS)Abdominal trauma or obstetrical manipulationEctopic pregnancyThreatened pregnancy loss after 12 weeks gestation with continuation of pregnancyPregnancy termination (spontaneous or induced) beyond 12 weeks gestationIf antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive.If RhoGAM is administered early in pregnancy (before 26 to 28 weeks), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-week intervals.Actual or threatened termination of pregnancy (spontaneous or induced) up to and including 12 weeks gestation Administer within 72 hoursMICRhoGAM(50 μg)(250 IU)RhoGAM may be administered if MICRhoGAM is not available.Transfusion of Rh-incompatible blood or blood productsAdminister within 72 hours of suspected or proven exposure to Rh-positive red blood cells.< 2.5 mL Rh-positive red blood cellsMICRhoGAM(50 μg)(250 IU)RhoGAM may be administered if MICRhoGAM is not available.2.5 - 15.0 mL Rh-positive red blood cellsRhoGAM(300 μg)(1500 IU)> 15.0 mL Rh-positive red blood cellsRhoGAM(300 μg)(1500 IU)(multiple syringes)Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. Administer 20 μg of RhoGAM per mL of Rh-positive red blood cell exposure. Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure.
11-Digit NDC Billing Format:
00562780525
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
25 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1790353 - rho(D) immune globulin, human 250 UNT (50 MCG) Prefilled Syringe
  • RxCUI: 1790353 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe
  • RxCUI: 731380 - MICRhoGAM 250 UNT (50 MCG) Prefilled Syringe
  • RxCUI: 731380 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe [MICRhoGAM]
  • RxCUI: 731380 - MICRhoGAM 250 UNT Prefilled Syringe
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Kedrion Biopharma Inc
    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.
    • Active Ingredient(s):
  • HUMAN RHO(D) IMMUNE GLOBULIN 300 ug/1
    • 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:
    BLA103777
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-09-2007
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0562-7805-25 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00562780525J2790Rho d immune globulin inj300 MCG (1500 IU)125125

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0562-7805-011 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
    0562-7805-055 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0562-7805-25?

    The NDC Packaged Code 0562-7805-25 is assigned to a package of 25 pouch in 1 carton / 1 injection, solution in 1 pouch (0562-7805-00) of Rhogam Ultra-filtered Plus, a plasma derivative labeled by Kedrion Biopharma Inc. The product's dosage form is injection, solution and is administered via intramuscular form.This product is billed for "EA" each discreet unit and contains an estimated amount of 25 billable units per package.

    Is NDC 0562-7805 included in the NDC Directory?

    Yes, Rhogam Ultra-filtered Plus with product code 0562-7805 is active and included in the NDC Directory. The product was first marketed by Kedrion Biopharma Inc on March 09, 2007 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 NDC billing unit for package 0562-7805-25?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 25.

    What is the 11-digit format for NDC 0562-7805-25?

    The 11-digit format is 00562780525. 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 4-4-2 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
    4-4-20562-7805-255-4-200562-7805-25