NDC 70257-053
HepaGam B
Human Hepatitis B Virus Immune Globulin
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 | 70257-053_0e592766-b538-4959-bff9-60d606310d3e |
| NDC | 70257-053 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HepaGam B |
| Generic Name | Human Hepatitis B Virus Immune Globulin |
| Dosage Form | Injection |
| Route of Administration | INTRAMUSCULAR; INTRAVENOUS |
| Marketing Start Date | 2018-06-20 |
| 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 | 2021-12-31 |
Packaging
NDC 70257-053-51
1 VIAL, GLASS in 1 CARTON (70257-053-51) > 1 mL in 1 VIAL, GLASS (70257-053-11)
| Marketing Start Date | 2018-06-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "HepaGam B" or generic name "Human Hepatitis B Virus Immune Globulin"
| 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) |
| 59730-4202 | NABI-HB | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
| 59730-4203 | NABI-HB | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Trademark Results [HepaGam B]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEPAGAM B 78676454 3303814 Live/Registered |
SAOL INTERNATIONAL LIMITED 2005-07-22 |
 HEPAGAM B 78628420 3336211 Live/Registered |
SAOL INTERNATIONAL LIMITED 2005-05-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.