Hyperrab Injection, Solution
NDC Package 13533-318-01

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

Hyperrab (rabies immune globulin (human)) injection is hYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. This formulation utilizes a injection, solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-318 and is authorized under FDA application BLA101144.

Identification & Billing

NDC Package Code
13533-318-01
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL (13533-318-10)
Product Code
13533-318
11-Digit Billing Format
13533031801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2043306 - rabies immune globulin, human 300 UNT in 1 mL Injection
  • RxCUI: 2043306 - 1 ML rabies immune globulin, human 300 UNT/ML Injection
  • RxCUI: 2043306 - rabies immune globulin, human 300 UNT per 1 ML Injection
  • RxCUI: 2043308 - HyperRAB 300 UNT in 1 mL Injection
  • RxCUI: 2043308 - 1 ML rabies immune globulin, human 300 UNT/ML Injection [HyperRAB]

Clinical Specifications

Proprietary Name
Hyperrab
Non-Proprietary Name
Rabies Immune Globulin (human)
Substance Name
Human Rabies Virus 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
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intramuscular - Administration within a muscle.
Active Ingredient(s)
HUMAN RABIES VIRUS IMMUNE GLOBULIN 300 [iU]/mL
Usage Information
HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitation of UsePersons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3)For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3)Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA101144
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-12-1974
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.

90375
Source: ASP
Rabies ig im/sc
HCPCS Dosage 150 IU
Units / Pkg 2

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 (13533-318). Click a package code to view its specific billing and regulatory data.

13533-318-03
1 VIAL in 1 CARTON / 3 mL in 1 VIAL (13533-318-30)
13533-318-05
1 VIAL in 1 CARTON / 5 mL in 1 VIAL (13533-318-50)

* 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 13533-318-01 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial (13533-318-10) of Hyperrab, a plasma derivative labeled by Grifols Usa, Llc. This injection, solution is formulated for infiltration; intramuscular use and contains human rabies virus 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 June 12, 1974. 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: 13533031801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
13533-318-01
11-Digit CMS (5-4-2)
13533-0318-01

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