Hyperrho Solution
NDC Package 13533-661-06

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

Package Information

Hyperrho (rho(d) immune globulin (human)) solution is hyperRHO S/D Mini-Dose is recommended to prevent the isoimmunization of Rho(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met:The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) antigen. The father is not known to be Rho(D) negative.Gestation is not more than 12 weeks at termination.Note: Rho(D) Immune Globulin (Human) prophylaxis is not indicated if the fetus or father can be determined to be Rh negative. This formulation utilizes a solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-661 and is authorized under FDA application BLA101141.

Identification & Billing

NDC Package Code
13533-661-06
Package Description
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (13533-661-60)
Product Code
13533-661
11-Digit Billing Format
13533066106
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: 898572 - HyperRHO Mini-Dose 250 UNT (50 MCG) Prefilled Syringe
  • RxCUI: 898572 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe [HyperRHO]
  • RxCUI: 898572 - HyperRHO 250 UNT Prefilled Syringe

Clinical Specifications

Proprietary Name
Hyperrho Mini-dose
Non-Proprietary Name
Rho(d) Immune Globulin (human)
Substance Name
Human Rho(d) Immune Globulin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HUMAN RHO(D) IMMUNE GLOBULIN 250 [iU]/mL
Pharmacologic Class
Usage Information
HyperRHO S/D Mini-Dose is recommended to prevent the isoimmunization of Rho(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met:The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) antigen. The father is not known to be Rho(D) negative.Gestation is not more than 12 weeks at termination.Note: Rho(D) Immune Globulin (Human) prophylaxis is not indicated if the fetus or father can be determined to be Rh negative. If the Rh status of the fetus is unknown, the fetus must be assumed to be Rho(D) positive, and HyperRHO S/D Mini-Dose should be administered to the mother.FOR ABORTIONS OR MISCARRIAGES OCCURRING AFTER 12 WEEKS’ GESTATION, A STANDARD DOSE OF Rho(D) IMMUNE GLOBULIN (HUMAN) IS INDICATED.HyperRHO S/D Mini-Dose should be administered within 3 hours or as soon as possible after spontaneous passage or surgical removal of the products of conception. However, if HyperRHO S/D Mini-Dose is not given within this time period, consideration should still be given to its administration since clinical studies in male volunteers have demonstrated the effectiveness of Rho(D) Immune Globulin (Human) in preventing isoimmunization as long as 72 hours after infusion of Rho(D) positive red cells. [9]

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA101141
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-14-1996
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.

J2788
Source: PDAC
INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, MINIDOSE, 50 MICROGRAMS (250 I.U.)
HCPCS Dosage 50 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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13533-661-06 identifies a specific commercial package of 10 syringe in 1 carton / 1 ml in 1 syringe (13533-661-60) of Hyperrho Mini-dose, a plasma derivative labeled by Grifols Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This 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 Grifols Usa, Llc on August 14, 1996. The current certification is valid through December 31, 2026.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533066106. 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 (5-3-2)
13533-661-06
11-Digit CMS (5-4-2)
13533-0661-06

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