NDC Code | 70504-0052-2 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (70504-0052-2) > 1 mL in 1 VIAL, SINGLE-DOSE (70504-0052-1) |
Product NDC | 70504-0052 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hepagam B |
Non-Proprietary Name | Hepatitis B Immune Globulin (human) |
Dosage Form | INJECTION, SOLUTION |
Usage | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20160701 |
Marketing Category Name | BLA |
Application Number | BLA125035 |
Manufacturer | Aptevo BioTherapeutics LLC |
Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Strength | 312 |
Strength Unit | [iU]/mL |
Pharmacy Classes | Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS] |