Hyperrho Solution
NDC Package 13533-631-11

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

Hyperrho (rho(d) immune globulin (human)) solution is none known. This formulation utilizes a solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-631 and is authorized under FDA application BLA101141.

Identification & Billing

NDC Package Code
13533-631-11
Package Description
10 CARTON in 1 CARTON / 1 SYRINGE in 1 CARTON (13533-631-03) / 1 mL in 1 SYRINGE (13533-631-20)
Product Code
13533-631
11-Digit Billing Format
13533063111
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: 731381 - rho(D) immune globulin, human 1500 UNT (300 MCG) Prefilled Syringe
  • RxCUI: 731381 - Rho(D) immune globulin, human 1500 UNT Prefilled Syringe
  • RxCUI: 898578 - HyperRHO Full Dose 1500 UNT (300 MCG) Prefilled Syringe
  • RxCUI: 898578 - Rho(D) immune globulin, human 1500 UNT Prefilled Syringe [HyperRHO]
  • RxCUI: 898578 - HyperRHO 1500 UNT Prefilled Syringe

Clinical Specifications

Proprietary Name
Hyperrho Full 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 1500 [iU]/mL
Pharmacologic Class
Usage Information
None known.

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.

J2790
Source: ASP
Rho d immune globulin inj
HCPCS Dosage 300 MCG (1500 IU)
Units / Pkg 10

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 (13533-631). Click a package code to view its specific billing and regulatory data.

13533-631-02
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (13533-631-20)

* 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 13533-631-11 identifies a specific commercial package of 10 carton in 1 carton / 1 syringe in 1 carton (13533-631-03) / 1 ml in 1 syringe (13533-631-20) of Hyperrho Full 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: 13533063111. 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)
13533-631-11
11-Digit CMS (5-4-2)
13533-0631-11

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