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 ID: 53270-0051_148e1fa7-efc7-47be-a20a-1e9a623852e2
• NDC: 53270-0051
• Product Type: Plasma Derivative
• Proprietary Name: HepaGam B
• Generic Name: Hepatitis B Immune Globulin (human)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2010-08-01
• Marketing Category: BLA / BLA
• Application Number: BLA125035
• Labeler Name: Cangene bioPharma Inc.
• Substance Name: HUMAN HEPATITIS
• Active Ingredient Strength: 312 [iU]/mL
• Pharm Classes: Human Immunoglo
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53270-0051-1

1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0051-1) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2010-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53270-0051-1 [53270005101]

HepaGam B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125035
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2010-08-01
• Marketing End Date: 2018-02-28

NDC 53270-0051-0 [53270005100]

HepaGam B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125035
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2019-04-09
• Marketing End Date: 2018-02-28

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	312 [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)"

NDC	Brand Name	Generic Name
53270-0051	HepaGam B	Hepatitis B Immune Globulin (Human)
53270-0052	HepaGam B	Hepatitis B Immune Globulin (Human)
70257-051	HepaGam B	Hepatitis B Immune Globulin Intravenous (Human)
70257-052	HepaGam B	Hepatitis B Immune Globulin Intravenous (Human)
70257-053	HepaGam B	human hepatitis B virus immune globulin
70257-054	HepaGam B	human hepatitis B virus immune globulin
70504-0051	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0052	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0053	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0054	HepaGam B	Hepatitis B Immune Globulin (Human)
13533-636	HYPERHEP B	HEPATITIS B IMMUNE GLOBULIN (HUMAN)
69800-4202	Nabi-HB	Hepatitis B Immune Globulin (Human)
69800-4203	Nabi-HB	Hepatitis B Immune Globulin (Human)