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HepaGam B
HepaGam B - 53270-0053-1 - (Hepatitis B Immune Globulin (Human))
Drug Information of HepaGam B
| Product NDC: | 53270-0053 |
| Proprietary Name: | HepaGam B |
| Non Proprietary Name: | Hepatitis B Immune Globulin (Human) |
| Active Ingredient(s): | 50 mg/mL & nbsp; Hepatitis B Immune Globulin (Human) |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of HepaGam B
| Product NDC: | 53270-0053 |
| Labeler Name: | Cangene bioPharma Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125035 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20100801 |
Package Information of HepaGam B
| Package NDC: | 53270-0053-1 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0053-1) > 1 mL in 1 VIAL, SINGLE-DOSE |
NDC Information of HepaGam B
| NDC Code | 53270-0053-1 |
| Proprietary Name | HepaGam B |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0053-1) > 1 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 53270-0053 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hepatitis B Immune Globulin (Human) |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20100801 |
| Marketing Category Name | BLA |
| Labeler Name | Cangene bioPharma Inc. |
| Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] |
