HepaGam B
These highlights do not include all the information needed to use HepaGam B safely and effectively. See full prescribing information for HepaGam B. HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. Greater than 312 international units per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006
Approved
Approval ID
b8a28ab4-6b20-47ab-8513-012d47db82f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2021
Manufacturers
FDA
Saol Therapeutics Inc.
DUNS: 080040201
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
human hepatitis B virus immune globulin
PRODUCT DETAILS
NDC Product Code70257-054
Application NumberBLA125035
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 16, 2020
Generic Namehuman hepatitis B virus immune globulin
INGREDIENTS (3)
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULINActive
Quantity: 312 [iU] in 1 mL
Code: XII270YC6M
Classification: ACTIB
human hepatitis B virus immune globulin
PRODUCT DETAILS
NDC Product Code70257-053
Application NumberBLA125035
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 16, 2020
Generic Namehuman hepatitis B virus immune globulin
INGREDIENTS (3)
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULINActive
Quantity: 312 [iU] in 1 mL
Code: XII270YC6M
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT