Product NDC: | 13533-800 |
Proprietary Name: | Gamunex-C |
Non Proprietary Name: | Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified |
Active Ingredient(s): | 10 g/100mL & nbsp; Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 13533-800 |
Labeler Name: | Grifols Therapeutics Inc. |
Product Type: | PLASMA DERIVATIVE |
FDA Application Number: | BLA125046 |
Marketing Category: | BLA |
Start Marketing Date: | 20101013 |
Package NDC: | 13533-800-20 |
Package Description: | 1 VIAL, GLASS in 1 CARTON (13533-800-20) > 50 mL in 1 VIAL, GLASS (13533-800-21) |
NDC Code | 13533-800-20 |
Proprietary Name | Gamunex-C |
Package Description | 1 VIAL, GLASS in 1 CARTON (13533-800-20) > 50 mL in 1 VIAL, GLASS (13533-800-21) |
Product NDC | 13533-800 |
Product Type Name | PLASMA DERIVATIVE |
Non Proprietary Name | Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20101013 |
Marketing Category Name | BLA |
Labeler Name | Grifols Therapeutics 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] |