NDC 13533-810
XEMBIFY
Immune Globulin Subcutaneous, Human-klhw
XEMBIFY is a Subcutaneous Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.
| Product ID | 13533-810_3ca18abe-d589-4c9a-b25c-5895bbb5ba4b |
| NDC | 13533-810 |
| Product Type | Plasma Derivative |
| Proprietary Name | XEMBIFY |
| Generic Name | Immune Globulin Subcutaneous, Human-klhw |
| Dosage Form | Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2019-07-03 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125683 |
| Labeler Name | GRIFOLS USA, LLC |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient Strength | 200 mg/mL |
| Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 13533-810-05
1 VIAL in 1 CARTON (13533-810-05) > 5 mL in 1 VIAL (13533-810-06)
| Marketing Start Date | 2019-07-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13533-810-20 [13533081020]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-21 [13533081021]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-51 [13533081051]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-11 [13533081011]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-06 [13533081006]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-50 [13533081050]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-10 [13533081010]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
NDC 13533-810-05 [13533081005]
XEMBIFY SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125683 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 200 mg/mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
Trademark Results [XEMBIFY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XEMBIFY 88223128 not registered Live/Pending |
GRIFOLS WORLDWIDE OPERATIONS LIMITED 2018-12-10 |
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