NDC 70257-053

HepaGam B

Human Hepatitis B Virus Immune Globulin

HepaGam B is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Human Hepatitis B Virus Immune Globulin.

Product ID70257-053_0e592766-b538-4959-bff9-60d606310d3e
NDC70257-053
Product TypeHuman Prescription Drug
Proprietary NameHepaGam B
Generic NameHuman Hepatitis B Virus Immune Globulin
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-06-20
Marketing CategoryBLA / BLA
Application NumberBLA125035
Labeler NameSaol Therapeutics Inc.
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 Through2021-12-31

Packaging

NDC 70257-053-51

1 VIAL, GLASS in 1 CARTON (70257-053-51) > 1 mL in 1 VIAL, GLASS (70257-053-11)
Marketing Start Date2018-06-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "HepaGam B" or generic name "Human Hepatitis B Virus Immune Globulin"

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)
59730-4202NABI-HBHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
59730-4203NABI-HBHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

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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