NDC 53270-0051

HepaGam B

Hepatitis B Immune Globulin (human)

HepaGam B is a Intramuscular; Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Cangene Biopharma Inc.. The primary component is Human Hepatitis.

Product ID53270-0051_148e1fa7-efc7-47be-a20a-1e9a623852e2
NDC53270-0051
Product TypePlasma Derivative
Proprietary NameHepaGam B
Generic NameHepatitis B Immune Globulin (human)
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2010-08-01
Marketing CategoryBLA / BLA
Application NumberBLA125035
Labeler NameCangene bioPharma Inc.
Substance NameHUMAN HEPATITIS
Active Ingredient Strength312 [iU]/mL
Pharm ClassesHuman Immunoglo
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53270-0051-1

1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0051-1) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53270-0051-1 [53270005101]

HepaGam B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125035
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-08-01
Marketing End Date2018-02-28

NDC 53270-0051-0 [53270005100]

HepaGam B INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125035
Product TypePLASMA DERIVATIVE
Marketing Start Date2019-04-09
Marketing End Date2018-02-28

Drug Details

Active Ingredients

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

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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