Immunoglobulin G Injectable Solution

Brand(s)
Bivigam, Carimune, Flebogamma, GamaSTAN, Gammagard, Gammaked, Gammaplex, Gamunex, Hizentra, Octagam, Privigen, Vivaglobin
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Bio Products Laboratory Limited (2015-09-10)
Oldest Current Product
1994-05-10
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\IMMUNOGLOBULIN G
SPL Active
INTRAMUSCULAR\INJECTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION, SOLUTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\LIQUID\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\SOLUTION\HUMAN IMMUNOGLOBULIN G
SUBCUTANEOUS\LIQUID\HUMAN IMMUNOGLOBULIN G
SUBCUTANEOUS\SOLUTION\HUMAN IMMUNOGLOBULIN G
SPL Moiety
INTRAMUSCULAR\INJECTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION, SOLUTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\INJECTION\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\LIQUID\HUMAN IMMUNOGLOBULIN G
INTRAVENOUS\SOLUTION\HUMAN IMMUNOGLOBULIN G
SUBCUTANEOUS\LIQUID\HUMAN IMMUNOGLOBULIN G
SUBCUTANEOUS\SOLUTION\HUMAN IMMUNOGLOBULIN G

product(s) by strength(s)

immunoglobulin g, human 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009442623GammagardBLABaxter Healthcare Corporation1994-05-10103133386f0fbf-6a1b-4a8a-a2f3-c912996e0ccd
2009442627GammagardBLABaxter Healthcare Corporation1994-05-10103133386f0fbf-6a1b-4a8a-a2f3-c912996e0ccd
3009442655GammagardBLABaxter Healthcare Corporation2011-01-03HUMAN IMMUNOGLOBULIN GKIT1031339ac2ccbf-1271-477c-9cc9-811838432506, ac8b6376-290c-43df-b560-c2182bf9b029
4009442656GammagardBLABaxter Healthcare Corporation1994-05-10103133bf8df9fd-bfdd-47c2-84d2-d91e50947bf6
5442060437PrivigenBLACsl Behring Ag2009-01-20HUMAN IMMUNOGLOBULIN GINTRAVENOUSLIQUID1252017e5649da-75be-4a42-8eeb-4aeba562c401
6442060438PrivigenBLACsl Behring Ag2009-01-20HUMAN IMMUNOGLOBULIN GINTRAVENOUSLIQUID1252017e5649da-75be-4a42-8eeb-4aeba562c401
7597306503BivigamBLANabi Biopharmaceuticals2013-02-04HUMAN IMMUNOGLOBULIN GINTRAVENOUSINJECTION, SOLUTION125389a80da7b0-fd11-4dcd-b58c-1a475147476d
8689820850OctagamBLAOctapharma Usa Inc2004-05-21HUMAN IMMUNOGLOBULIN GINTRAVENOUSSOLUTION125062a36a12dc-16be-b135-466f-393954f428a7
9761250900GammakedBLAKedrion Biopharma, Inc2010-10-13HUMAN IMMUNOGLOBULIN GINTRAVENOUSINJECTION1250468c004331-7a91-8046-7510-9b9b7d33ced7

immunoglobulin g, human 120 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1442060416CarimuneBLACsl Behring Ag2009-02-10HUMAN IMMUNOGLOBULIN GINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION102367610b905a-50d3-48f0-919a-69cc99aab5a8
2442060418CarimuneBLACsl Behring Ag2009-02-10HUMAN IMMUNOGLOBULIN GINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION102367610b905a-50d3-48f0-919a-69cc99aab5a8

immunoglobulin g, human 160 mg/ml injectable solution

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000537596VivaglobinBLACsl Behring Llc2006-01-09HUMAN IMMUNOGLOBULIN GSUBCUTANEOUSSOLUTION12511588eac3b8-55a5-4451-9d25-c30e43ab7068

immunoglobulin g, human 180 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135330635GamaSTANBLAGrifols1996-08-14HUMAN IMMUNOGLOBULIN GINTRAMUSCULARINJECTION101134561f48de-2697-4a35-8233-bd1cdb73438f

immunoglobulin g, human 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1442060451HizentraBLACsl Behring Ag2011-10-03HUMAN IMMUNOGLOBULIN GSUBCUTANEOUSLIQUID1253507b58f5ff-0316-49a3-b585-1f6003ddb953
2442060455HizentraBLACsl Behring Ag2011-10-03HUMAN IMMUNOGLOBULIN GSUBCUTANEOUSLIQUID1253507b58f5ff-0316-49a3-b585-1f6003ddb953

immunoglobulin g, human 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1642088234GammaplexBLABio Products Laboratory Limited2010-11-01HUMAN IMMUNOGLOBULIN GINTRAVENOUSSOLUTION1253296c3ce068-59f0-413b-9f93-85fb597d55e5
2682090843OctagamBLAOctapharma Ab2006-04-14HUMAN IMMUNOGLOBULIN GINTRAVENOUSSOLUTION125062c906fa75-6235-032a-284f-cd0b93794ff9
3689820840OctagamBLAOctapharma Usa Inc2004-05-21HUMAN IMMUNOGLOBULIN GINTRAVENOUSSOLUTION125062de00abeb-d635-eddc-b603-10708ecef5aa

application(s)

#idtitleapprovedtradenamesfda division
1101134Immune Globulin (Human) Application1944-01-11BayGam, GammaSTANCBER
2102367Immune Globulin Intravenous (Human) Application1984-06-07Carimune, Carimune NF, Panglobulin, SandoglobulinCBER
3103133Immune Globulin Intravenous (Human) Application1986-02-18Gammagard, Gammagard S/D, IveegamCBER
4125046Immune Globulin Injection (Human) Application2003-08-2710% Caprylate/Chromatography PurifiedGamunex-C, GAMMAKED (Kendrion)CBER
5125062Immune Globulin Intravenous (Human) Application2004-05-21OCTAGAMCBER
6125077Immune Globulin Intravenous (Human)Flebogamma 5%; Flebogamma; Flebogamma 5% Application2003-12-15DIFCBER
7125105Immune Globulin Infusion (Human)Polygam Application2005-04-27GAMMAGARD LIQUID, KIOVIG, LQCBER
8125201Immune Globulin Intravenous (Human) Application2007-07-2610% LiquidPrivigenCBER
9125329Immune Globulin Intravenous (Human), 5% LiquidGammaplex Application2009-09-17CBER
10125350Immune Globulin Subcutaneous (Human), 20% LiquidHizentra Application2010-03-04CBER
11125389Immune Globulin Intravenous (Human) Application2012-12-19BivigamCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
126d73f6e-25b7-42b4-bf2e-903bc4c9f2f7 (view SPL)These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD S/D, Immune Globulin Intravenous (Human)Solvent Detergent TreatedIgA less than or equal to 2.2 g/mL in a 5% SolutionInitial U.S. Approval: 1994otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-12-161009442620
22cf22c72-64ac-45be-b7c6-d20340730096 (view SPL)These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF.FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administrationInitial U.S. Approval: 2006otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2014-08-3113619530004
3386f0fbf-6a1b-4a8a-a2f3-c912996e0ccd (view SPL)These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD S/D, Immune Globulin Intravenous (Human)Solvent Detergent TreatedIgA less than or equal to 2.2 g/mL in a 5% SolutionInitial U.S. Approval: 1994otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-052009442623, 009442627, 009442625
4561f48de-2697-4a35-8233-bd1cdb73438f (view SPL)Immune Globulin (Human)GamaSTAN S/DSolvent/Detergent TreatedotherPlasma DerivativeGrifolsMANUFACTURE2013-09-2721135330635
5610b905a-50d3-48f0-919a-69cc99aab5a8 (view SPL)Immune Globulin Intravenous (Human) Carimune NF, NanofilteredotherPlasma DerivativeCsl Behring AgMANUFACTURE2013-10-028442060416, 442060418, 442060417
66c3ce068-59f0-413b-9f93-85fb597d55e5 (view SPL)These highlights do not include all the information needed to use GAMMAPLEX safely and effectively. See full prescribing information for GAMMAPLEX GAMMAPLEX Immune Globulin Intravenous [Human], 5% Liquid, for intravenous use Initial U.S. Approval: 2009otherPlasma DerivativeBio Products Laboratory LimitedANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-09-1012642088234
76c96884d-4eb9-482b-981e-8a8207158150 (view SPL)These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD S/D, Immune Globulin Intravenous (Human)Solvent Detergent TreatedIgA less than or equal to 2.2 g/mL in a 5% SolutionInitial U.S. Approval: 1994otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-12-167009442620
87b58f5ff-0316-49a3-b585-1f6003ddb953 (view SPL)These highlights do not include all the information needed to use HIZENTRA safely and effectively. See full prescribing information for HIZENTRA. HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid Initial U.S. Approval: 2010otherPlasma DerivativeCsl Behring AgMANUFACTURE2015-06-0213442060451, 442060455, 442060452, 442060454
97e5649da-75be-4a42-8eeb-4aeba562c401 (view SPL)These highlights do not include all the information needed to use PRIVIGEN safely and effectively. See full prescribing information for PRIVIGEN. PRIVIGEN, Immune Globulin Intravenous (Human), 10% LiquidInitial U.S. Approval: 2007otherPlasma DerivativeCsl Behring AgMANUFACTURE2013-12-2018442060437, 442060438, 442060436, 442060439
10810c8752-a7cb-0bce-777d-8539429773c2 (view SPL)Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.prescriptionHuman PrescriptionOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2009-09-094674670843
1184bf3b45-f329-408d-a971-55c098f92cb0 (view SPL)These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD S/D, Immune Globulin Intravenous (Human)Solvent Detergent TreatedIgA less than or equal to 2.2 g/mL in a 5% SolutionInitial U.S. Approval: 1994otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-12-161009442620
1288eac3b8-55a5-4451-9d25-c30e43ab7068 (view SPL)These highlights do not include all the information needed to use Vivaglobin safely and effectively. See full prescribing information for Vivaglobin.VivaglobinImmune Globulin Subcutaneous (Human)16% LiquidInitial U.S. Approval: 2006prescriptionHuman PrescriptionCsl Behring LlcMANUFACTURE2010-07-158000537596
138c004331-7a91-8046-7510-9b9b7d33ced7 (view SPL)These highlights do not include all the information needed to use GAMMAKED safely and effectively.See full prescribing information for GAMMAKED. GAMMAKED, [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] Initial U.S. Approval: 2003otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2013-09-3018761250900
149ac2ccbf-1271-477c-9cc9-811838432506 (view SPL)GAMMAGARD S/DImmune Globulin Intravenous (Human)IgA less than 1 g/mL in a 5% SolutionSolvent Detergent TreatedotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-06-176009442655
159d42adca-0dd7-4df7-864d-5a7feee52130 (view SPL)These highlights do not include all the information needed to use GAMMAGARD LIQUID safely and effectively. See full prescribing information for GAMMAGARD LIQUID.GAMMAGARD LIQUID, Immune Globulin Infusion (Human), 10% Solution, for intravenous and subcutaneous administration Initial U.S. Approval: 2005otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-058009442700
16a36a12dc-16be-b135-466f-393954f428a7 (view SPL)Octagam, Immune Globulin Intravenous (Human) 10% Liquid Preparation Initial U.S. Approval: - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.otherPlasma DerivativeOctapharma Usa Inc2014-12-155689820850
17a80da7b0-fd11-4dcd-b58c-1a475147476d (view SPL)These highlights do not include all the information needed to use BIVIGAM safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human), 10% Liquid BIVIGAM Initial U.S. Approval : 2012otherPlasma DerivativeNabi Biopharmaceuticalsmanufacture2015-05-227597306503, 597306502
18ac8b6376-290c-43df-b560-c2182bf9b029 (view SPL)GAMMAGARD S/DImmune Globulin Intravenous (Human)IgA less than 1 g/mL in a 5% SolutionSolvent Detergent TreatedotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-06-176009442655
19ade6b84a-e95b-0a49-3296-f56208fdf35b (view SPL)These highlights do not include all the information needed to use GAMUNEX-C safely and effectively. See full prescribing information for GAMUNEX-C. GAMUNEX-C, [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] Initial U.S. Approval: 2003otherPlasma DerivativeGrifolsmanufacture2014-07-1524135330800
20bf8df9fd-bfdd-47c2-84d2-d91e50947bf6 (view SPL)These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD S/D, Immune Globulin Intravenous (Human)IgA less than or equal to 1 g/mL in a 5% SolutionSolvent Detergent TreatedInitial U.S. Approval: 1994otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-052009442656, 009442658
21c906fa75-6235-032a-284f-cd0b93794ff9 (view SPL)Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.otherPlasma DerivativeOctapharma Ab2009-09-091682090843
22de00abeb-d635-eddc-b603-10708ecef5aa (view SPL)Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.otherPlasma DerivativeOctapharma Usa Inc2015-08-172689820840
23e9ffa954-ccf0-4cfd-93f8-ddf795c62b07 (view SPL)GAMMAGARD S/D Immune Globulin Intravenous (Human)0.5gIgA less than 2.2 g/mL in a 5% SolutionotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-06-175009442620
24f9bf6322-75b4-4ccf-9a4b-4724203f5eef (view SPL)These highlights do not include all the information needed to use Flebogamma 10% DIF safely and effectively. See full prescribing information for Flebogamma 10% DIFFlebogamma 10% DIF [Immune Globulin Intravenous (Human)]For intravenous administration, 10% Liquid PreparationInitial U.S. Approval: 2010otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2014-07-0113619530005

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII