NDC 76125-900
GAMMAKED
Immune Globulin (human)
GAMMAKED is a Intravenous; Subcutaneous Injection in the Plasma Derivative category. It is labeled and distributed by Kedrion Biopharma, Inc.. The primary component is Human Immunoglobulin G.
| Product ID | 76125-900_a7164c72-baa7-4e49-a763-e5c75478ce2f |
| NDC | 76125-900 |
| Product Type | Plasma Derivative |
| Proprietary Name | GAMMAKED |
| Generic Name | Immune Globulin (human) |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2010-10-13 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125046 |
| Labeler Name | KEDRION BIOPHARMA, INC. |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient Strength | 10 g/100mL |
| 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 |
Packaging
NDC 76125-900-01
1 VIAL, GLASS in 1 CARTON (76125-900-01) > 10 mL in 1 VIAL, GLASS (76125-900-02)
| Marketing Start Date | 2010-10-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76125-900-10 [76125090010]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 76125-900-01 [76125090001]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 76125-900-25 [76125090025]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 76125-900-02 [76125090002]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-01-07 |
NDC 76125-900-11 [76125090011]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2013-01-07 |
NDC 76125-900-26 [76125090026]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2013-01-07 |
NDC 76125-900-20 [76125090020]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 76125-900-21 [76125090021]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2013-01-07 |
NDC 76125-900-51 [76125090051]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2013-01-07 |
NDC 76125-900-50 [76125090050]
GAMMAKED INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 10 g/100mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
NDC Crossover Matching brand name "GAMMAKED" or generic name "Immune Globulin (human)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 76125-900 | GAMMAKED | Immune Globulin (Human) |
| 61953-0004 | Flebogamma | Immune Globulin (Human) |
| 13533-335 | GamaSTAN | immune globulin (human) |
| 13533-635 | GAMASTAN | IMMUNE GLOBULIN (HUMAN) |
| 13533-800 | Gamunex-C | Immune Globulin (Human) |
Trademark Results [GAMMAKED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMAKED 85359561 4207375 Live/Registered |
KEDRION S.p.A. 2011-06-29 |
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