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  4. NDC Product Code: 70257-052 Hepagam B

NDC 70257-052 Hepagam B

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70257-052?
  4. Hepagam B Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
70257-052
Proprietary Name:
Hepagam B
Non-Proprietary Name: [1]
Hepatitis B Immune Globulin Intravenous (human)
Substance Name: [2]
Human Hepatitis B Virus Immune Globulin
NDC Directory Status:
Human Prescription Drug
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.
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Saol Therapeutics Inc.
    Labeler Code:
    70257
    Product Label ID:
    2ba8df27-4f35-41f6-8148-0c213c18df4e
    FDA Application Number: [6]
    BLA125035
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    03-01-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 70257-052-51

    Package Description: 1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (70257-052-11)

    Product Details

    What is NDC 70257-052?

    The NDC code 70257-052 is assigned by the FDA to the product Hepagam B which is a human prescription drug product labeled by Saol Therapeutics Inc.. The generic name of Hepagam B is hepatitis b immune globulin intravenous (human). The product's dosage form is injection and is administered via intramuscular; intravenous form. The product is distributed in a single package with assigned NDC code 70257-052-51 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (70257-052-11). 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 Hepagam B?

    This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

    What are Hepagam 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 Hepagam 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 Hepagam 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 Hepagam 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: 1658125 - hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
    • RxCUI: 1658125 - 5 ML hepatitis B immune globulin 312 UNT/ML Injection
    • RxCUI: 1658147 - hepatitis B immune globulin (human) > 312 UNT/ML in 1 ML Injection
    • RxCUI: 1658147 - 1 ML hepatitis B immune globulin 312 UNT/ML Injection
    • RxCUI: 1658159 - HepaGam B > 312 UNT/ML in 1 ML Injection

    Which are the Pharmacologic Classes for Hepagam 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".