| Product NDC: | 61953-0004 |
| Proprietary Name: | Flebogamma |
| Non Proprietary Name: | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient(s): | .05 g/mL & nbsp; HUMAN IMMUNOGLOBULIN G |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61953-0004 |
| Labeler Name: | Instituto Grifols, S.A. |
| Product Type: | PLASMA DERIVATIVE |
| FDA Application Number: | BLA125077 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20061221 |
| Package NDC: | 61953-0004-5 |
| Package Description: | 1 VIAL in 1 CARTON (61953-0004-5) > 400 mL in 1 VIAL (61953-0004-0) |
| NDC Code | 61953-0004-5 |
| Proprietary Name | Flebogamma |
| Package Description | 1 VIAL in 1 CARTON (61953-0004-5) > 400 mL in 1 VIAL (61953-0004-0) |
| Product NDC | 61953-0004 |
| Product Type Name | PLASMA DERIVATIVE |
| Non Proprietary Name | HUMAN IMMUNOGLOBULIN G |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20061221 |
| Marketing Category Name | BLA |
| Labeler Name | Instituto Grifols, S.A. |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Strength Number | .05 |
| Strength Unit | g/mL |
| Pharmaceutical Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] |