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  4. NDC Product Code: 13533-636 Hyperhep B

NDC 13533-636 Hyperhep B

Hepatitis B Immune Globulin (human) Injection Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13533-636?
  5. Hyperhep B Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
13533-636
Proprietary Name:
Hyperhep B
Non-Proprietary Name: [1]
Hepatitis B Immune Globulin (human)
Substance Name: [2]
Human Hepatitis B Virus Immune Globulin
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Grifols Usa, Llc
    Labeler Code:
    13533
    Product Label ID:
    cda35690-672f-46cd-8520-e37f4d66a8d7
    FDA Application Number: [6]
    BLA101146
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-09-1996
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - COLORLESS OR PALE YELLOW OR LIGHT BROWN)

    Product Packages

    NDC Code 13533-636-01

    Package Description: 1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (13533-636-10)

    NDC Code 13533-636-02

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS (13533-636-20)

    NDC Code 13533-636-03

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (13533-636-30)

    NDC Code 13533-636-05

    Package Description: 1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS (13533-636-50)

    Product Details

    What is NDC 13533-636?

    The NDC code 13533-636 is assigned by the FDA to the product Hyperhep B which is a plasma derivative product labeled by Grifols Usa, Llc. The generic name of Hyperhep B is hepatitis b immune globulin (human). The product's dosage form is injection and is administered via intramuscular form. The product is distributed in 4 packages with assigned NDC codes 13533-636-01 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (13533-636-10), 13533-636-02 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass (13533-636-20), 13533-636-03 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (13533-636-30), 13533-636-05 1 vial, glass in 1 carton / 5 ml in 1 vial, glass (13533-636-50). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Hyperhep B?

    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:

    What are Hyperhep B Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Hyperhep B UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M)
    • HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (Active Moiety)

    Which are Hyperhep B Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Hyperhep B?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Hyperhep B?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".