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 ID0944-2850_03df6e5f-c663-40d3-abed-560073fadb7c
NDC0944-2850
Product TypePlasma Derivative
Proprietary NameCUVITRU
Generic NameImmune Globulin Subcutaneous (human)
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-10-18
Marketing CategoryBLA / BLA
Application NumberBLA125596
Labeler NameBaxalta US Inc
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength200 mg/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

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 Date2016-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0944-2850-03 [00944285003]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-07 [00944285007]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-08 [00944285008]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-02 [00944285002]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-05 [00944285005]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-10 [00944285010]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2019-02-15

NDC 0944-2850-04 [00944285004]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-09 [00944285009]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2019-02-15

NDC 0944-2850-01 [00944285001]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

NDC 0944-2850-06 [00944285006]

CUVITRU INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125596
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-10-18

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G200 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
CUVITRU
86815189 5147716 Live/Registered
BAXALTA INCORPORATED
2015-11-10

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