| 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] |