| NDC Code | 49591-051-51 |
| Package Description | 1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05) |
| Product NDC | 49591-051 |
| Product Type Name | PLASMA DERIVATIVE |
| Proprietary Name | Hepagam B |
| Non-Proprietary Name | Human Hepatitis B Virus Immune Globulin |
| Dosage Form | INJECTION, SOLUTION |
| Usage | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20231201 |
| Marketing Category Name | BLA |
| Application Number | BLA125035 |
| Manufacturer | Kamada Ltd. |
| Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
| Strength | 312 |
| Strength Unit | [iU]/mL |
| Pharmacy Classes | Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT] |