NDC 70504-0053

HepaGam B

Hepatitis B Immune Globulin (human)

HepaGam B is a Intramuscular; Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Aptevo Biotherapeutics Llc. The primary component is Human Hepatitis B Virus Immune Globulin.

Product ID70504-0053_b3195063-4432-4936-9597-43eed79f87cf
NDC70504-0053
Product TypeHuman Prescription Drug
Proprietary NameHepaGam B
Generic NameHepatitis B Immune Globulin (human)
Dosage FormSolution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-07-01
Marketing CategoryBLA / BLA
Application NumberBLA125035
Labeler NameAptevo BioTherapeutics LLC
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active Ingredient Strength312 [iU]/mL
Pharm ClassesHuman Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70504-0053-2

1 VIAL in 1 CARTON (70504-0053-2) > 1 mL in 1 VIAL (70504-0053-1)
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70504-0053-1 [70504005301]

HepaGam B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-07-01

NDC 70504-0053-2 [70504005302]

HepaGam B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-02

Drug Details

Active Ingredients

IngredientStrength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN312 [iU]/mL

OpenFDA Data

SPL SET ID:f4c4619a-d314-4f73-adba-93ee7488aa4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658159
  • 1658125
  • 1658423
  • 1658147
  • Pharmacological Class

    • Human Immunoglobulin [EPC]
    • Passively Acquired Immunity [PE]
    • Virus Neutralization [MoA]
    • Virus-specific Hyperimmune Globulins [EXT]
    • Immunoglobulins [CS]

    NDC Crossover Matching brand name "HepaGam B" or generic name "Hepatitis B Immune Globulin (human)"

    NDCBrand NameGeneric Name
    53270-0051HepaGam BHepatitis B Immune Globulin (Human)
    53270-0052HepaGam BHepatitis B Immune Globulin (Human)
    70257-051HepaGam BHepatitis B Immune Globulin Intravenous (Human)
    70257-052HepaGam BHepatitis B Immune Globulin Intravenous (Human)
    70257-053HepaGam Bhuman hepatitis B virus immune globulin
    70257-054HepaGam Bhuman hepatitis B virus immune globulin
    70504-0051HepaGam BHepatitis B Immune Globulin (Human)
    70504-0052HepaGam BHepatitis B Immune Globulin (Human)
    70504-0053HepaGam BHepatitis B Immune Globulin (Human)
    70504-0054HepaGam BHepatitis B Immune Globulin (Human)
    13533-636HYPERHEP BHEPATITIS B IMMUNE GLOBULIN (HUMAN)
    69800-4202Nabi-HBHepatitis B Immune Globulin (Human)
    69800-4203Nabi-HBHepatitis B Immune Globulin (Human)

    Trademark Results [HepaGam B]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HEPAGAM B
    HEPAGAM B
    78676454 3303814 Live/Registered
    SAOL INTERNATIONAL LIMITED
    2005-07-22
    HEPAGAM B
    HEPAGAM B
    78628420 3336211 Live/Registered
    SAOL INTERNATIONAL LIMITED
    2005-05-12

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