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: | 76125-900-25 |
Package Description: | 1 VIAL, GLASS in 1 CARTON (76125-900-25) > 25 mL in 1 VIAL, GLASS (76125-900-26) |
NDC Code | 76125-900-25 |
Proprietary Name | GAMMAKED |
Package Description | 1 VIAL, GLASS in 1 CARTON (76125-900-25) > 25 mL in 1 VIAL, GLASS (76125-900-26) |
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] |