Octagam Immune Globulin (Human) is a Intravenous Solution in the Plasma Derivative category. It is labeled and distributed by Octapharma Usa Inc. The primary component is Human Immunoglobulin G.
| Product ID | 68982-850_20a70f93-66f3-8e97-1473-e35f04433821 |
| NDC | 68982-850 |
| Product Type | Plasma Derivative |
| Proprietary Name | Octagam Immune Globulin (Human) |
| Generic Name | Immune Globulin |
| Dosage Form | Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2004-05-21 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125062 |
| Labeler Name | Octapharma USA Inc |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient Strength | 100 mg/mL |
| Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2004-05-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2004-05-21 |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2004-05-21 |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2004-05-21 |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-06-04 |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2004-05-21 |
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 100 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 67467-843 | Octagam Immune Globulin (Human) | Immune Globulin |
| 68209-843 | Octagam Immune Globulin (Human) | Immune Globulin |
| 68982-840 | Octagam Immune Globulin (Human) | Immune Globulin |
| 68982-850 | Octagam Immune Globulin (Human) | Immune Globulin |