Product NDC: | 61953-0005 |
Proprietary Name: | Flebogamma DIF |
Non Proprietary Name: | Human Immunoglobulin G |
Active Ingredient(s): | 5 g/50mL & nbsp; Human Immunoglobulin G |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 61953-0005 |
Labeler Name: | Instituto Grifols, S.A. |
Product Type: | PLASMA DERIVATIVE |
FDA Application Number: | BLA125077 |
Marketing Category: | BLA |
Start Marketing Date: | 20100727 |
Package NDC: | 61953-0005-2 |
Package Description: | 1 VIAL in 1 CARTON (61953-0005-2) > 100 mL in 1 VIAL (61953-0005-5) |
NDC Code | 61953-0005-2 |
Proprietary Name | Flebogamma DIF |
Package Description | 1 VIAL in 1 CARTON (61953-0005-2) > 100 mL in 1 VIAL (61953-0005-5) |
Product NDC | 61953-0005 |
Product Type Name | PLASMA DERIVATIVE |
Non Proprietary Name | Human Immunoglobulin G |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20100727 |
Marketing Category Name | BLA |
Labeler Name | Instituto Grifols, S.A. |
Substance Name | HUMAN IMMUNOGLOBULIN G |
Strength Number | 5 |
Strength Unit | g/50mL |
Pharmaceutical Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] |