FLEBOGAMMA DIF is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.
Product ID | 61953-0005_2223ed3b-37af-4523-96eb-98a787e33cd7 |
NDC | 61953-0005 |
Product Type | Plasma Derivative |
Proprietary Name | FLEBOGAMMA DIF |
Generic Name | Immune Globulin Intravenous (human) |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2010-07-27 |
Marketing Category | BLA / BLA |
Application Number | BLA125077 |
Labeler Name | GRIFOLS USA, LLC |
Substance Name | HUMAN IMMUNOGLOBULIN G |
Active Ingredient Strength | 5 g/50mL |
Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2010-07-27 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-10-23 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-10-23 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-07-27 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-10-23 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-07-27 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-07-27 |
Ingredient | Strength |
---|---|
HUMAN IMMUNOGLOBULIN G | 5 g/50mL |
NDC | Brand Name | Generic Name |
---|---|---|
61953-0005 | FLEBOGAMMA DIF | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) |
61953-0004 | Flebogamma DIF | Flebogamma DIF |
0944-2623 | GAMMAGARD | Immune Globulin Intravenous (Human) |
0944-2625 | GAMMAGARD | Immune Globulin Intravenous (Human) |
0944-2627 | GAMMAGARD | Immune Globulin Intravenous (Human) |
0944-2656 | GAMMAGARD | Immune Globulin Intravenous (Human) |
0944-2658 | GAMMAGARD | Immune Globulin Intravenous (Human) |
0069-1011 | Panzyga | immune globulin intravenous (human) |
0069-1109 | Panzyga | immune globulin intravenous (human) |
0069-1224 | Panzyga | immune globulin intravenous (human) |
0069-1312 | Panzyga | immune globulin intravenous (human) |
0069-1415 | Panzyga | immune globulin intravenous (human) |
0069-1558 | Panzyga | immune globulin intravenous (human) |
68982-820 | Panzyga | immune globulin intravenous (human) |
68982-822 | Panzyga | immune globulin intravenous (human) |