Albumin Human, USP Injectable Solution

Brand(s)
Albuked, Albuminar-20, Albuminar-25, Albuminar-5, Alburx, Albutein, Buminate, Flexbumin, Human Albumin Grifols, Kedbumin, Plasbumin
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Csl Behring Ag (2015-08-25)
Oldest Current Product
1942-10-21
License(s)
BLA, EXPORT ONLY
RxNORM
INJECTABLE SOLUTION\ALBUMIN HUMAN, USP
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ALBUMIN HUMAN
INTRAVENOUS\SOLUTION\ALBUMIN HUMAN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ALBUMIN HUMAN
INTRAVENOUS\SOLUTION\ALBUMIN HUMAN

product(s) by strength(s)

albumin human, usp 200 mg/ml injectable solution

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1009440482BuminateEXPORT ONLYBaxter Healthcare Corporation1954-03-17ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION6ad848db-2867-42e1-81ae-c435e44c37e2
2009440492FlexbuminEXPORT ONLYBaxter Healthcare Corporation2002-08-09ALBUMIN HUMANINTRAVENOUSSOLUTION98b96ee2-86d2-4056-bdda-4d75d72d891f

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135330691PlasbuminBLAGrifols1994-09-26ALBUMIN HUMANINTRAVENOUSSOLUTION1011385b334e41-5297-540c-5fc1-cd7b845c5685
2619530001Human Albumin GrifolsBLAGrifols Usa, Llc1995-02-17ALBUMIN HUMANINTRAVENOUSSOLUTION103352a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc
3674670633BLAOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17ALBUMIN HUMANINTRAVENOUSSOLUTION12515490f0c351-3977-2b84-0a6a-e9cb091430ca
4685165215AlbuteinBLAGrifols Usa, Llc1978-08-15ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION102478d18a7e13-1ef0-495c-aa57-ace2e446a823
5761250791AlbukedBLAKedrion Biopharma, Inc1981-07-28ALBUMIN HUMANINTRAVENOUSSOLUTION1011383d7b50cd-029a-ab08-83dc-8f87ffa22ef1

albumin human, usp 250 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009440490BuminateBLABaxter Healthcare Corporation1954-03-17ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION1014524efc78ab-6b74-4ce9-bd3e-9411130ea81b
2135330692PlasbuminBLAGrifols1994-09-26ALBUMIN HUMANINTRAVENOUSSOLUTION1011382eeb6b69-2013-c0a2-5e2f-0365114d41b4
3442060251AlburxBLACsl Behring Ag2009-01-06ALBUMIN HUMANINTRAVENOUSSOLUTION102366ad74b7f5-b380-47ab-b19d-eef92c8eb7a4
4674670643BLAOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17ALBUMIN HUMANINTRAVENOUSSOLUTION1251544ddaae99-05e1-e05c-e63c-0c58965d157d
5685165216AlbuteinBLAGrifols Usa, Llc1978-08-15ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION102478de634e31-d99b-4ed6-ba0a-07904d745aeb
6761250784AlbukedBLAKedrion Biopharma, Inc1942-10-21ALBUMIN HUMANINTRAVENOUSSOLUTION1011380df480bb-be5e-0e7f-1331-fd4de81d33a6
7761790025KedbuminBLAKedrion S.P.A2011-09-15ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION12538457bd6811-8619-11e0-9d78-0800200c9a66

albumin human, usp 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000537670Albuminar-5BLACsl Behring Llc2009-01-06ALBUMIN HUMANINTRAVENOUSSOLUTION1039554923eb2d-99bc-4e3d-8608-1f58adb83a8f
2009440495FlexbuminBLABaxter Healthcare Corporation2014-07-31ALBUMIN HUMANINTRAVENOUSINJECTION, SOLUTION10145279094f4e-5f5c-44d6-b563-d6078eafe83a
3135330685PlasbuminBLAGrifols1976-08-26ALBUMIN HUMANINTRAVENOUSSOLUTION1011381065ab0c-86fd-03a5-ace5-6f40eaae8595
4442060310AlburxBLACsl Behring Ag2009-01-06ALBUMIN HUMANINTRAVENOUSSOLUTION10236656a6ad30-153d-4adf-9d92-a82ec19fa1b8
5674670623BLAOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17ALBUMIN HUMANINTRAVENOUSSOLUTION125154a912d27c-00cb-2ed0-effe-2d88d1f2ca67
6761250790AlbukedBLAKedrion Biopharma, Inc1976-08-26ALBUMIN HUMANINTRAVENOUSSOLUTION101138fac1e3bd-5b30-f251-c5ae-2226caecf51d

application(s)

#idtitleapprovedtradenamesfda division
1101138Albumin (Human) Application1942-10-21Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5CBER
2101452Albumin (Human) Application1954-03-03Buminate, Buminate 20%, Buminate 25%, Buminate 5%, FlexbuminCBER
3102366Albumin (Human) Application1976-07-23AlbuRxCBER
4102478Albumin (Human) Application1978-08-15AlbuteinCBER
5103352Albumin (Human) Application1995-02-17CBER
6103955Albumin (Human) Application1949-05-17Albuminar, Albuminar-20, Albuminar-25, Albuminar-5CBER
7125154Albumin (Human) Application2006-10-17CBER
8125384Albumin (Human) Application2011-06-03kedbuminCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101d78cc3-765c-89a9-7a60-b578e5723cbb (view SPL)Albumin (Human) 5%, USPAlbuked 5otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2012-07-318761250785
207734008-9dd3-b006-0825-65147c58e1ac (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006otherPlasma DerivativeOctapharma Usa Inc2015-07-081689820643
30df480bb-be5e-0e7f-1331-fd4de81d33a6 (view SPL)Albumin (Human) 25%, USPAlbuked 25otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2012-07-318761250784
41065ab0c-86fd-03a5-ace5-6f40eaae8595 (view SPL)Albumin (Human) 5%, USPPlasbumin-5otherPlasma DerivativeGrifolsMANUFACTURE2012-07-316135330685
518a9c174-f892-e45f-ca4b-bd5a180c1539 (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 20% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 20%. ALBUMIN (HUMAN) 20% For intravenous use only 20% solution Initial U.S. Approval: 2006otherPlasma DerivativeOctapharma Usa Inc2015-07-081689820633
62eeb6b69-2013-c0a2-5e2f-0365114d41b4 (view SPL)Albumin (Human) 25%, USPPlasbumin-25otherPlasma DerivativeGrifolsMANUFACTURE2014-09-158135330692
73d7b50cd-029a-ab08-83dc-8f87ffa22ef1 (view SPL)Albumin (Human) 20%, USPAlbuked 20otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2014-09-011761250791
84923eb2d-99bc-4e3d-8608-1f58adb83a8f (view SPL)Albumin (Human) USP, 5% Albuminar-5otherPlasma DerivativeCsl Behring LlcMANUFACTURE2015-02-199000537670
94ddaae99-05e1-e05c-e63c-0c58965d157d (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006prescriptionHuman PrescriptionOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2008-08-014674670643
104efc78ab-6b74-4ce9-bd3e-9411130ea81b (view SPL)BUMINATE 25%, Albumin (Human), USP, 25% SolutionotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-10-222009440490
1156a6ad30-153d-4adf-9d92-a82ec19fa1b8 (view SPL)Albumin (Human) 5% Solution AlbuRx 5otherPlasma DerivativeCsl Behring AgMANUFACTURE2015-08-256442060310
1257bd6811-8619-11e0-9d78-0800200c9a66 (view SPL)These highlights do not include all the information needed to use KEDBUMIN safely and effectively. See full prescribing information for KEDBUMIN [Albumin (Human) U.S.P.] sterile, aqueous solution for single dose intravenous administrationInitial U.S. Approval: June, 2011.otherPlasma DerivativeKedrion S.P.AMANUFACTURE2012-08-319761790025
135b334e41-5297-540c-5fc1-cd7b845c5685 (view SPL)Albumin (Human) 20%, USPPlasbumin-20otherPlasma DerivativeGrifolsMANUFACTURE2014-09-156135330691
146ad848db-2867-42e1-81ae-c435e44c37e2 (view SPL)BUMINATE 20%, Albumin (Human), USP, 20% SolutionotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-10-222009440482
1579094f4e-5f5c-44d6-b563-d6078eafe83a (view SPL)FLEXBUMIN 5% Albumin (Human), USP, 5% Solution in GALAXY single-dose ContainerotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE, PACK, STERILIZE2014-02-181009440495
1690f0c351-3977-2b84-0a6a-e9cb091430ca (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 20% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 20%. ALBUMIN (HUMAN) 20% For intravenous use only 20% solution Initial U.S. Approval: 2006prescriptionHuman PrescriptionOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2008-08-015674670633
179284ff93-4712-eedd-e225-7ceb670178e6 (view SPL)Albumin (Human) 25%, USPPlasbumin-25otherPlasma DerivativeGrifolsMANUFACTURE2012-07-316135330684
1898b96ee2-86d2-4056-bdda-4d75d72d891f (view SPL)FLEXBUMIN 20%, Albumin (Human), USP, 20% Solution in GALAXY single-dose ContainerotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE, PACK, STERILIZE2014-10-223009440492
199c45986e-4e62-4f7d-971c-bec74dc4d234 (view SPL)These highlights do not include all the information needed to use Albutein 5% safely and effectively. See full prescribing information for Albutein 5%.Albutein 5%Albumin (Human) U.S.P.5% solution Initial U.S. Approval: 1978otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2013-12-193685165214
20a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc (view SPL)These highlights do not include all the information needed to use Human Albumin Grifols 20% safely and effectively. See full prescribing information for Human Albumin Grifols 20%.Human Albumin Grifols 20%Albumin (Human) U.S.P.20% solution Initial U.S. Approval: 1995otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2013-12-196619530001
21a901aa63-3347-4a12-8c74-e7cdd6edbddc (view SPL)Albumin (Human) USP, 20% Albuminar-20otherPlasma DerivativeCsl Behring LlcMANUFACTURE2013-08-055000537695
22a912d27c-00cb-2ed0-effe-2d88d1f2ca67 (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 5% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 5%. ALBUMIN (HUMAN) 5% For intravenous use only 5% solution Initial U.S. Approval: 2006prescriptionHuman PrescriptionOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2008-08-014674670623
23ad5163c6-c2c8-4356-a704-ddbd38bf997b (view SPL)These highlights do not include all the information needed to use Human Albumin Grifols 25% safely and effectively. See full prescribing information for Human Albumin Grifols 25%.Human Albumin Grifols 25%Albumin (Human) U.S.P. 25% solution Initial U.S. Approval: 2003otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2013-12-196619530002
24ad74b7f5-b380-47ab-b19d-eef92c8eb7a4 (view SPL)Albumin (Human) 25% Solution AlbuRx 25otherPlasma DerivativeCsl Behring AgMANUFACTURE2015-08-255442060251
25aebc5b6d-2fd3-4674-8505-783c90e84827 (view SPL)BUMINATE 5%, ALBUMIN (HUMAN), USP, 5% SOLUTIONotherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-10-222009440491
26bdb4e167-27a2-4b50-b245-43df9cd535cb (view SPL)FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution in GALAXY single-dose ContainerotherPlasma DerivativeBaxter Healthcare CorporationLABEL, MANUFACTURE, PACK, STERILIZE2014-10-224009440493
27bfea0d08-0e7f-a057-7b70-49b909b05a6a (view SPL)These highlights do not include all the information needed to use ALBUMIN (HUMAN) 5% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 5%. ALBUMIN (HUMAN) 5% For intravenous use only 5% solution Initial U.S. Approval: 2006otherPlasma DerivativeOctapharma Usa Inc2015-07-081689820623
28c1f5ecb3-5488-1e92-a432-e06bf3a9f120 (view SPL)Albumin (Human) 20%, USPAlbuked 20otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2012-07-318761250783
29c4163cb7-df73-4ab1-b952-0ac1a7a1e7fc (view SPL)Albumin (Human) USP, 25% Albuminar-25otherPlasma DerivativeCsl Behring LlcMANUFACTURE2014-09-257000537680
30d18a7e13-1ef0-495c-aa57-ace2e446a823 (view SPL)These highlights do not include all the information needed to use Albutein 20% safely and effectively. See full prescribing information for Albutein 20%.Albutein 20%Albumin (Human) U.S.P.20% solutionInitial U.S. Approval: 1978otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2013-12-193685165215
31d1db9f87-afbb-ec28-fbec-c3677458f8c0 (view SPL)Albumin (Human) 20%, USPPlasbumin-20otherPlasma DerivativeGrifolsMANUFACTURE2012-07-316135330683
32de634e31-d99b-4ed6-ba0a-07904d745aeb (view SPL)These highlights do not include all the information needed to use Albutein 25% safely and effectively. See full prescribing information for Albutein 25%.Albutein 25%Albumin (Human) U.S.P.25% solutionInitial U.S. Approval: 1978otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2013-12-193685165216
33ead60f3e-9dcc-7afe-2220-4f2381f3c140 (view SPL)Albumin (Human) 5%, USPPlasbumin-5otherPlasma DerivativeGrifolsMANUFACTURE2014-09-156135330690
34fac1e3bd-5b30-f251-c5ae-2226caecf51d (view SPL)Albumin (Human) 5%, USPAlbuked 5otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2014-09-151761250790
35face90dc-a227-3ec2-1645-f74eb9dac68c (view SPL)Albumin (Human) 25%, USPAlbuked 25otherPlasma DerivativeKedrion Biopharma, IncMANUFACTURE2014-09-011761250792

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