NDC 61953-0005

FLEBOGAMMA DIF

Immune Globulin Intravenous (human)

FLEBOGAMMA DIF is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.

Product ID61953-0005_2223ed3b-37af-4523-96eb-98a787e33cd7
NDC61953-0005
Product TypePlasma Derivative
Proprietary NameFLEBOGAMMA DIF
Generic NameImmune Globulin Intravenous (human)
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-07-27
Marketing CategoryBLA / BLA
Application NumberBLA125077
Labeler NameGRIFOLS USA, LLC
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength5 g/50mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61953-0005-1

1 VIAL in 1 CARTON (61953-0005-1) > 50 mL in 1 VIAL (61953-0005-4)
Marketing Start Date2010-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61953-0005-5 [61953000505]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-10-23

NDC 61953-0005-4 [61953000504]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-10-23

NDC 61953-0005-3 [61953000503]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-07-27

NDC 61953-0005-6 [61953000506]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-10-23

NDC 61953-0005-1 [61953000501]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-07-27

NDC 61953-0005-2 [61953000502]

FLEBOGAMMA DIF INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125077
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2010-07-27

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G5 g/50mL

Pharmacological Class

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

NDC Crossover Matching brand name "FLEBOGAMMA DIF" or generic name "Immune Globulin Intravenous (human)"

NDCBrand NameGeneric Name
61953-0005FLEBOGAMMA DIFIMMUNE GLOBULIN INTRAVENOUS (HUMAN)
61953-0004Flebogamma DIFFlebogamma DIF
0944-2623GAMMAGARDImmune Globulin Intravenous (Human)
0944-2625GAMMAGARDImmune Globulin Intravenous (Human)
0944-2627GAMMAGARDImmune Globulin Intravenous (Human)
0944-2656GAMMAGARDImmune Globulin Intravenous (Human)
0944-2658GAMMAGARDImmune Globulin Intravenous (Human)
0069-1011Panzygaimmune globulin intravenous (human)
0069-1109Panzygaimmune globulin intravenous (human)
0069-1224Panzygaimmune globulin intravenous (human)
0069-1312Panzygaimmune globulin intravenous (human)
0069-1415Panzygaimmune globulin intravenous (human)
0069-1558Panzygaimmune globulin intravenous (human)
68982-820Panzygaimmune globulin intravenous (human)
68982-822Panzygaimmune globulin intravenous (human)

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