| Product NDC: | 76125-900 |
| Proprietary Name: | GAMMAKED |
| Non Proprietary Name: | Human Immunoglobulin G |
| Active Ingredient(s): | 10 g/100mL & nbsp; Human Immunoglobulin G |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 76125-900 |
| Labeler Name: | KEDRION BIOPHARMA, INC |
| Product Type: | PLASMA DERIVATIVE |
| FDA Application Number: | BLA125046 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20101013 |
| Package NDC: | 76125-900-20 |
| Package Description: | 1 VIAL, GLASS in 1 CARTON (76125-900-20) > 200 mL in 1 VIAL, GLASS (76125-900-21) |
| NDC Code | 76125-900-20 |
| Proprietary Name | GAMMAKED |
| Package Description | 1 VIAL, GLASS in 1 CARTON (76125-900-20) > 200 mL in 1 VIAL, GLASS (76125-900-21) |
| Product NDC | 76125-900 |
| Product Type Name | PLASMA DERIVATIVE |
| Non Proprietary Name | Human Immunoglobulin G |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20101013 |
| Marketing Category Name | BLA |
| Labeler Name | KEDRION BIOPHARMA, INC |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Strength Number | 10 |
| Strength Unit | g/100mL |
| Pharmaceutical Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] |