| Product NDC: | 61953-0003 |
| Proprietary Name: | Flebogamma |
| Non Proprietary Name: | Immune Globulin (Human) |
| Active Ingredient(s): | .5 g/10mL & nbsp; Immune Globulin (Human) |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61953-0003 |
| Labeler Name: | Instituto Grifols, S.A. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125077 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20031215 |
| Package NDC: | 61953-0003-1 |
| Package Description: | 1 VIAL in 1 CARTON (61953-0003-1) > 10 mL in 1 VIAL |
| NDC Code | 61953-0003-1 |
| Proprietary Name | Flebogamma |
| Package Description | 1 VIAL in 1 CARTON (61953-0003-1) > 10 mL in 1 VIAL |
| Product NDC | 61953-0003 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Immune Globulin (Human) |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20031215 |
| Marketing Category Name | BLA |
| Labeler Name | Instituto Grifols, S.A. |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Strength Number | .5 |
| Strength Unit | g/10mL |
| Pharmaceutical Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] |