Rhogam Ultra-filtered Plus Injection, Solution
NDC Package 0562-7805-01

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

Rhogam Ultra-filtered Plus (human rho(d) immune globulin) injection is 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 formulation utilizes a injection, solution delivery system. Marketed by Kedrion Biopharma Inc, this product is identified by NDC 0562-7805 and is authorized under FDA application BLA103777.

Identification & Billing

NDC Package Code
0562-7805-01
Package Description
1 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
Product Code
0562-7805
11-Digit Billing Format
00562780501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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

Clinical Specifications

Proprietary Name
Rhogam Ultra-filtered Plus
Non-Proprietary Name
Human Rho(d) Immune Globulin
Substance Name
Human Rho(d) Immune Globulin
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HUMAN RHO(D) IMMUNE GLOBULIN 300 ug/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Kedrion Biopharma Inc
Product Type
Plasma Derivative
FDA Application #
BLA103777
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-09-2007
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.

J2790
Source: PDAC
INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, FULL DOSE, 300 MICROGRAMS (1500 I.U.)
HCPCS Dosage 300 MCG
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 (0562-7805). Click a package code to view its specific billing and regulatory data.

0562-7805-05
5 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
0562-7805-25
25 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)

* 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 0562-7805-01 identifies a specific commercial package of 1 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. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intramuscular 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 Kedrion Biopharma Inc on March 09, 2007. The current certification is valid through December 31, 2026.

How is this Kedrion Biopharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00562780501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (4-4-2)
0562-7805-01
11-Digit CMS (5-4-2)
00562-7805-01

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