NDC 76125-900

GAMMAKED

Immune Globulin (human)

GAMMAKED is a Intravenous; Subcutaneous Injection in the Plasma Derivative category. It is labeled and distributed by Kedrion Biopharma, Inc.. The primary component is Human Immunoglobulin G.

Product ID76125-900_a7164c72-baa7-4e49-a763-e5c75478ce2f
NDC76125-900
Product TypePlasma Derivative
Proprietary NameGAMMAKED
Generic NameImmune Globulin (human)
Dosage FormInjection
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2010-10-13
Marketing CategoryBLA / BLA
Application NumberBLA125046
Labeler NameKEDRION BIOPHARMA, INC.
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength10 g/100mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76125-900-01

1 VIAL, GLASS in 1 CARTON (76125-900-01) > 10 mL in 1 VIAL, GLASS (76125-900-02)
Marketing Start Date2010-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76125-900-10 [76125090010]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-10-13

NDC 76125-900-01 [76125090001]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-10-13

NDC 76125-900-25 [76125090025]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-10-13

NDC 76125-900-02 [76125090002]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-01-07

NDC 76125-900-11 [76125090011]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-01-07

NDC 76125-900-26 [76125090026]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-01-07

NDC 76125-900-20 [76125090020]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-10-13

NDC 76125-900-21 [76125090021]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-01-07

NDC 76125-900-51 [76125090051]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-01-07

NDC 76125-900-50 [76125090050]

GAMMAKED INJECTION
Marketing CategoryBLA
Application NumberBLA125046
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-10-13

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G10 g/100mL

Pharmacological Class

  • Human Immunoglobulin G [EPC]
  • Passively Acquired Immunity [PE]
  • Antigen Neutralization [MoA]
  • Immunoglobulins [CS]

NDC Crossover Matching brand name "GAMMAKED" or generic name "Immune Globulin (human)"

NDCBrand NameGeneric Name
76125-900GAMMAKEDImmune Globulin (Human)
61953-0004FlebogammaImmune Globulin (Human)
13533-335GamaSTANimmune globulin (human)
13533-635GAMASTANIMMUNE GLOBULIN (HUMAN)
13533-800Gamunex-CImmune Globulin (Human)

Trademark Results [GAMMAKED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMAKED
GAMMAKED
85359561 4207375 Live/Registered
KEDRION S.p.A.
2011-06-29

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