NDC Package 13533-318-05 Hyperrab

Rabies Immune Globulin (human) Injection, Solution Infiltration; Intramuscular - View Billable Units, 11-Digit Format, RxNorm

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:
13533-318-05
Package Description:
1 VIAL in 1 CARTON / 5 mL in 1 VIAL (13533-318-50)
Product Code:
Proprietary Name:
Hyperrab
Non-Proprietary Name:
Rabies Immune Globulin (human)
Substance Name:
Human Rabies Virus Immune Globulin
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.
11-Digit NDC Billing Format:
13533031805
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    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):
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intramuscular - Administration within a muscle.
  • Sample Package:
    No
    FDA Application Number:
    BLA101144
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-12-1974
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    13533-318-011 VIAL in 1 CARTON / 1 mL in 1 VIAL (13533-318-10)
    13533-318-031 VIAL in 1 CARTON / 3 mL in 1 VIAL (13533-318-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13533-318-05?

    The NDC Packaged Code 13533-318-05 is assigned to a package of 1 vial in 1 carton / 5 ml in 1 vial (13533-318-50) of Hyperrab, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection, solution and is administered via infiltration; intramuscular form.

    Is NDC 13533-318 included in the NDC Directory?

    Yes, Hyperrab with product code 13533-318 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on June 12, 1974 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 13533-318-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 13533-318-05?

    The 11-digit format is 13533031805. 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 5-3-2 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
    5-3-213533-318-055-4-213533-0318-05