NDC 0944-2700
GAMMAGARD Liquid
Immune Globulin Infusion (human)
GAMMAGARD Liquid is a Intravenous; Subcutaneous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is Human Immunoglobulin G.
| Product ID | 0944-2700_0637f33f-72e9-4624-bd0e-d854891e9107 |
| NDC | 0944-2700 |
| Product Type | Plasma Derivative |
| Proprietary Name | GAMMAGARD Liquid |
| Generic Name | Immune Globulin Infusion (human) |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2005-04-27 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125105 |
| Labeler Name | Baxalta US 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 |
Packaging
NDC 0944-2700-02
1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) > 10 mL in 1 BOTTLE, GLASS (0944-2700-08)
| Marketing Start Date | 2005-04-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0944-2700-04 [00944270004]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2005-04-27 |
NDC 0944-2700-05 [00944270005]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2005-04-27 |
NDC 0944-2700-02 [00944270002]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2005-04-27 |
NDC 0944-2700-08 [00944270008]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
NDC 0944-2700-09 [00944270009]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
NDC 0944-2700-10 [00944270010]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
NDC 0944-2700-06 [00944270006]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2005-04-27 |
NDC 0944-2700-07 [00944270007]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2011-01-28 |
NDC 0944-2700-13 [00944270013]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
NDC 0944-2700-03 [00944270003]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2005-04-27 |
NDC 0944-2700-12 [00944270012]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
NDC 0944-2700-11 [00944270011]
GAMMAGARD Liquid INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125105 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2015-03-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 100 mg/mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
Trademark Results [GAMMAGARD Liquid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMAGARD LIQUID 86305472 4671336 Live/Registered |
BAXALTA INCORPORATED 2014-06-10 |
 GAMMAGARD LIQUID 78623679 not registered Dead/Abandoned |
Baxter International Inc. 2005-05-05 |
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