NDC 64208-8235
Gammaplex
Human Immunoglobulin G
Gammaplex is a Intravenous Solution in the Plasma Derivative category. It is labeled and distributed by Bio Products Laboratory Limited. The primary component is Human Immunoglobulin G.
| Product ID | 64208-8235_250ae01b-7f0d-4ed6-936e-b92b5f9a3aa1 |
| NDC | 64208-8235 |
| Product Type | Plasma Derivative |
| Proprietary Name | Gammaplex |
| Generic Name | Human Immunoglobulin G |
| Dosage Form | Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-04-07 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125329 |
| Labeler Name | Bio Products Laboratory Limited |
| 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 |
Packaging
NDC 64208-8235-5
1 BOTTLE, GLASS in 1 CARTON (64208-8235-5) > 50 mL in 1 BOTTLE, GLASS (64208-8235-1)
| Marketing Start Date | 2017-04-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 64208-8235-2 [64208823502]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
NDC 64208-8235-7 [64208823507]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
NDC 64208-8235-5 [64208823505]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
NDC 64208-8235-6 [64208823506]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
NDC 64208-8235-3 [64208823503]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
NDC 64208-8235-1 [64208823501]
Gammaplex SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125329 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-07 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 5 g/50mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
NDC Crossover Matching brand name "Gammaplex" or generic name "Human Immunoglobulin G"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 64208-8235 | Gammaplex | Gammaplex |
| 64208-8234 | Gammaplex | Gammaplex |
| 44206-417 | Carimune | HUMAN IMMUNOGLOBULIN G |
| 44206-418 | Carimune | HUMAN IMMUNOGLOBULIN G |
| 44206-451 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-452 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-454 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-455 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-456 | Hizentra | HUMAN IMMUNOGLOBULIN G |
| 44206-436 | Privigen | Human Immunoglobulin G |
| 44206-437 | Privigen | Human Immunoglobulin G |
| 44206-438 | Privigen | Human Immunoglobulin G |
| 44206-439 | Privigen | Human Immunoglobulin G |
Trademark Results [Gammaplex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMAPLEX 78245696 2869439 Live/Registered |
BIO PRODUCTS LABORATORY LIMITED 2003-05-05 |
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