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  5. NDC Package Code: 13533-636-01 Hyperhep B

NDC Package 13533-636-01 Hyperhep B

Hepatitis B Immune Globulin (human) Injection Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

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:
13533-636-01
Package Description:
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (13533-636-10)
Product Code:
13533-636
Proprietary Name:
Hyperhep B
Non-Proprietary Name:
Hepatitis B Immune Globulin (human)
Substance Name:
Human Hepatitis B Virus Immune Globulin
Usage Information:
Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9)HyperHEP B is indicated for post-exposure prophylaxis in the following situations:
11-Digit NDC Billing Format:
13533063601
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1658163 - hepatitis B immune globulin (human) >220 UNT in 1 ML Injection
  • RxCUI: 1658163 - 1 ML hepatitis B immune globulin 220 UNT/ML Injection
  • RxCUI: 1658163 - hepatitis B immune globulin 220 UNT per 1 ML Injection
  • RxCUI: 1658165 - HyperHEP B S/D >220 UNT in 1 ML Injection
  • RxCUI: 1658165 - 1 ML hepatitis B immune globulin 220 UNT/ML Injection [Hyperhep B]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 220 [iU]/mL
    • Pharmacologic Class(es):
  • Human Immunoglobulin - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
  • Virus Neutralization - [MoA] (Mechanism of Action)
  • Virus-specific Hyperimmune Globulins - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    BLA101146
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-09-1996
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 13533-636-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    1353306360190371Hep b ig im1 ML1111

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    13533-636-021 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS (13533-636-20)
    13533-636-031 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (13533-636-30)
    13533-636-051 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS (13533-636-50)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13533-636-01?

    The NDC Packaged Code 13533-636-01 is assigned to a package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (13533-636-10) of Hyperhep B, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection and is administered via intramuscular form.

    Is NDC 13533-636 included in the NDC Directory?

    Yes, Hyperhep B with product code 13533-636 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on October 09, 1996 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 13533-636-01?

    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 13533-636-01?

    The 11-digit format is 13533063601. 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
    5-3-213533-636-015-4-213533-0636-01