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) |