NDC 69800-4203

Nabi-HB

Hepatitis B Immune Globulin (human)

Nabi-HB is a Intramuscular Liquid in the Human Prescription Drug category. It is labeled and distributed by Adma Biologics, Inc.. The primary component is Human Hepatitis B Virus Immune Globulin.

Product ID69800-4203_739a1a44-e3bc-4ef7-a928-cfa9d8c80c5f
NDC69800-4203
Product TypeHuman Prescription Drug
Proprietary NameNabi-HB
Generic NameHepatitis B Immune Globulin (human)
Dosage FormLiquid
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2001-10-23
Marketing CategoryBLA / BLA
Application NumberBLA103945
Labeler NameADMA Biologics, Inc.
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active Ingredient Strength1560 [iU]/5mL
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 69800-4203-1

1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) > 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2)
Marketing Start Date2001-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69800-4203-1 [69800420301]

Nabi-HB LIQUID
Marketing CategoryBLA
Application NumberBLA103945
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-10-23

Drug Details

Active Ingredients

IngredientStrength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN1560 [iU]/5mL

OpenFDA Data

SPL SET ID:47fe1a99-5078-4b89-84fa-9e8387baec5c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658148
  • 1658127
  • 1658125
  • 1658147
  • UPC Code
  • 0369800420310
  • 0369800420211
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nabi-HB" or generic name "Hepatitis B Immune Globulin (human)"

    NDCBrand NameGeneric Name
    59730-4202NABI-HBHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
    59730-4203NABI-HBHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
    69800-4202Nabi-HBHepatitis B Immune Globulin (Human)
    69800-4203Nabi-HBHepatitis B Immune Globulin (Human)
    53270-0051HepaGam BHepatitis B Immune Globulin (Human)
    53270-0052HepaGam BHepatitis B Immune Globulin (Human)
    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)

    Trademark Results [Nabi-HB]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NABI-HB
    NABI-HB
    75621967 2635779 Live/Registered
    ADMA BIOMANUFACTURING, LLC
    1999-01-14

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