NDC 70257-052

HepaGam B

Hepatitis B Immune Globulin Intravenous (human)

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 ID: 70257-052_0f41590a-72d3-40fb-8da8-412686748fcb
• NDC: 70257-052
• Product Type: Human Prescription Drug
• Proprietary Name: HepaGam B
• Generic Name: Hepatitis B Immune Globulin Intravenous (human)
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-03-01
• Marketing Category: BLA / BLA
• Application Number: BLA125035
• Labeler Name: Saol Therapeutics Inc.
• Substance Name: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
• Active Ingredient Strength: 312 [iU]/mL
• Pharm Classes: Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70257-052-51

1 VIAL, GLASS in 1 CARTON (70257-052-51) > 1 mL in 1 VIAL, GLASS (70257-052-11)

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70257-052-11 [70257005211]

HepaGam B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125035
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-01

NDC 70257-052-51 [70257005251]

HepaGam B INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125035
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	312 [iU]/mL

OpenFDA Data

• SPL SET ID: 2ba8df27-4f35-41f6-8148-0c213c18df4e
• Manufacturer:
  • Saol Therapeutics Inc.
• UNII:
  • XII270YC6M
• 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]
• 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 Intravenous (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)