NDC 0944-2850
CUVITRU
Immune Globulin Subcutaneous (human)
CUVITRU is a 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 | 0944-2850_03df6e5f-c663-40d3-abed-560073fadb7c |
| NDC | 0944-2850 |
| Product Type | Plasma Derivative |
| Proprietary Name | CUVITRU |
| Generic Name | Immune Globulin Subcutaneous (human) |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2016-10-18 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125596 |
| Labeler Name | Baxalta US Inc |
| 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 | 2022-12-31 |
Packaging
NDC 0944-2850-01
1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) > 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)
| Marketing Start Date | 2016-10-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0944-2850-03 [00944285003]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-07 [00944285007]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-08 [00944285008]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-02 [00944285002]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-05 [00944285005]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-10 [00944285010]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-02-15 |
NDC 0944-2850-04 [00944285004]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-09 [00944285009]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-02-15 |
NDC 0944-2850-01 [00944285001]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
NDC 0944-2850-06 [00944285006]
CUVITRU INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125596 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-10-18 |
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]
Trademark Results [CUVITRU]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUVITRU 86815189 5147716 Live/Registered |
BAXALTA INCORPORATED 2015-11-10 |
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