Hydroxychloroquine Oral Tablet

Brand(s)
Plaquenil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Prasco Laboratories (2015-06-04)
Oldest Current Product
1995-11-30
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\HYDROXYCHLOROQUINE
FDAOB
ORAL\TABLET\HYDROXYCHLOROQUINE SULFATE
SPL Active
ENTERAL\TABLET, FILM COATED\HYDROXYCHLOROQUINE SULFATE
ORAL\TABLET, COATED\HYDROXYCHLOROQUINE SULFATE
ORAL\TABLET, FILM COATED\HYDROXYCHLOROQUINE SULFATE
ORAL\TABLET\HYDROXYCHLOROQUINE SULFATE
SPL Moiety
ENTERAL\TABLET, FILM COATED\HYDROXYCHLOROQUINE
ORAL\TABLET, COATED\HYDROXYCHLOROQUINE
ORAL\TABLET, FILM COATED\HYDROXYCHLOROQUINE
ORAL\TABLET\HYDROXYCHLOROQUINE

product(s) by strength(s)

hydroxychloroquine sulfate 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870562PlaquenilNDACovis Pharmaceuticals, Inc.2013-06-28HYDROXYCHLOROQUINE SULFATEORALTABLETNDA009768631ed616-f23c-43c9-b63b-f53707c077cb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001432128ANDAWest-Ward Pharmaceutical Corp2007-08-15HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA0407603a047f49-ccb5-4cb6-b0d6-8abfa9c39f2e
2003780373ANDAMylan Pharmaceuticals Inc.1998-06-18HYDROXYCHLOROQUINE SULFATEENTERALTABLET, FILM COATEDANDA040274ff0c9d83-6d86-4d22-939b-a838bffbcfd0
3007811407ANDASandoz Inc1995-11-30HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA0401049d22f0a8-170b-4c3e-8c2e-a5cf64b9958b, b5869e45-27fc-4f33-80db-4a509b8256c1
4516600296ANDAOhm Laboratories Inc.2009-01-07HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA0407661bd923b1-f9e9-484d-a713-1329654d7ca4
5633040296ANDARnabaxy Pharmaceuticals Inc.2009-01-07HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA04076622d4d993-b86d-478e-ac6d-7bcd217e9906
6658410633ANDACadila Healthcare Limited2008-01-03HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA0406571aa44bff-9a62-48b4-a520-98d7d524e3a9
7669930057NDA AUTHORIZED GENERICPrasco Laboratories2014-12-12HYDROXYCHLOROQUINE SULFATEORALTABLETNDA0097686016af90-6311-4f35-bfc3-ce49c105ba4f
8683820096ANDAZydus Pharmaceuticals (Usa) Inc.2008-01-03HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATEDANDA040657805a1acd-2e0d-48f1-af6b-0e5d8e06c228

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1005910698ANDAWatson Laboratories, Inc.1995-11-30HYDROXYCHLOROQUINE SULFATEORALTABLET, COATEDANDA040133adf36d25-d86e-4d2d-b90c-e29f1394667d
2433530794ANDAAphena Pharma Solutions - Tennessee, Llc2012-02-29HYDROXYCHLOROQUINE SULFATEORALTABLET422910320ANDA0401338a99dbe0-2055-4513-b182-0416ceecd5f1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440578ANDABlenheim Pharmacal, Inc.2013-12-20HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED633040296ANDA0407660fd85527-b048-3f4a-e054-00144ff8d46c
2216950486ANDARebel Distributors Corp2009-01-07HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED633040296ANDA04076616ea7eee-51c9-4305-9808-358e3ace31bd
3332610933ANDAAidarex Pharmaceuticals Llc2009-01-07HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED633040296ANDA040766c293257e-ecd1-4c41-994e-0fe15dee41d2
4422910318ANDAAvkare, Inc.2014-05-19HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED516600296ANDA0407663ce83016-a5fc-71cf-92df-b8194f6b525d
5493490162ANDARemedyrepack Inc.2011-04-13HYDROXYCHLOROQUINE SULFATEORALTABLET633040296ANDA0407662ed338b7-d0d8-4e8c-96b7-af6346ad3189
6548683821ANDAPhysicians Total Care, Inc.1996-07-09HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED633040296ANDA040766d5a1c868-b92f-4386-b8f9-8719dd785954
7551542074ANDACardinal Health2008-08-05HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED680840269ANDA0406576971241c-8323-456e-91a4-a404a9e100de
8551543429ANDACardinal Health1995-11-30HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED007811407ANDA0401041dd8d688-8dce-4b06-aeb1-3447caba1cba
9604290700ANDAGolden State Medical Supply, Inc.2007-08-15HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED001432128ANDA040760ed80a489-672a-406f-b623-ee78ec150bed
10619190132ANDADirect Rx2014-01-01HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED683820096ANDA04065788bd448d-bac7-4839-816a-8b800d7705c4
11637390777ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2008-01-03HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED683820096ANDA040657b47e12d3-0395-4462-b856-2ecb033f11e6
12663360555ANDADispensing Solutions, Inc.2009-01-07HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED633040296ANDA04076671a8ea7d-e71d-4b71-871e-b592dd7ad047
13680840269ANDAAmerican Health Packaging2008-08-05HYDROXYCHLOROQUINE SULFATEORALTABLET, FILM COATED683820096ANDA040657a2d7be5a-98ee-4292-8715-46573dbe1c5b
14681510511PlaquenilNDACarilion Materials Management2013-06-28HYDROXYCHLOROQUINE SULFATEORALTABLET249870562NDA00976835314d43-3dec-46dd-8975-56f257b2f408

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040081HYDROXYCHLOROQUINE SULFATETEVA PHARMACEUTICALS USA1994-09-30ANDA040081_001
2ANDA040104HYDROXYCHLOROQUINE SULFATESANDOZ INC1995-11-30ANDA040104_001
3ANDA040133HYDROXYCHLOROQUINE SULFATETrueWATSON LABORATORIES INC1995-11-30ANDA040133_001
4ANDA040150HYDROXYCHLOROQUINE SULFATETrueSANDOZ INC1996-01-27ANDA040150_001
5ANDA040274HYDROXYCHLOROQUINE SULFATEMYLAN PHARMACEUTICALS INC1998-05-29ANDA040274_001
6ANDA040657HYDROXYCHLOROQUINE SULFATEZYDUS PHARMACEUTICALS USA INC2007-09-21ANDA040657_001
7ANDA040760HYDROXYCHLOROQUINE SULFATEHIKMA PHARMACEUTICALS LLC2007-08-15ANDA040760_001
8ANDA040766HYDROXYCHLOROQUINE SULFATEIPCA LABORATORIES LTD2007-06-14ANDA040766_001
9NDA009768PLAQUENILCONCORDIA PHARMACEUTICALS INCNDA009768_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040081_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB1994-09-30HYDROXYCHLOROQUINE SULFATE
2ANDA040104_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB1995-11-30HYDROXYCHLOROQUINE SULFATE
3ANDA040133_001discontinuedHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalse1995-11-30HYDROXYCHLOROQUINE SULFATE
4ANDA040150_001discontinuedHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalse1996-01-27HYDROXYCHLOROQUINE SULFATE
5ANDA040274_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB1998-05-29HYDROXYCHLOROQUINE SULFATE
6ANDA040657_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB2007-09-21HYDROXYCHLOROQUINE SULFATE
7ANDA040760_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB2007-08-15HYDROXYCHLOROQUINE SULFATE
8ANDA040766_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETFalseAB2007-06-14HYDROXYCHLOROQUINE SULFATE
9NDA009768_001RXHYDROXYCHLOROQUINE SULFATE (200MG)ORALTABLETTrueABPLAQUENIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10fd85527-b048-3f4a-e054-00144ff8d46c (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-242105440578
216ea7eee-51c9-4305-9808-358e3ace31bd (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-291216950486
31959d645-6b82-4f4d-b1f2-af644dec7c8f (view SPL)PLAQUENILHYDROXYCHLOROQUINE SULFATE, USPprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-04-028000241562
41aa44bff-9a62-48b4-a520-98d7d524e3a9 (view SPL)Hydroxychloroquine sulfate tablets, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-221658410633
51bd923b1-f9e9-484d-a713-1329654d7ca4 (view SPL)Hydroxychloroquine Sulfate Tablets, USP 200 mg*prescriptionHuman PrescriptionOhm Laboratories Inc.manufacture2014-03-131516600296
61dd8d688-8dce-4b06-aeb1-3447caba1cba (view SPL)HydroxychloroquineSulfate Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-092551543429
722d4d993-b86d-478e-ac6d-7bcd217e9906 (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.Manufacture2014-03-254633040296
82ed338b7-d0d8-4e8c-96b7-af6346ad3189 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-133493490162
935314d43-3dec-46dd-8975-56f257b2f408 (view SPL)PLAQUENIL HYDROXYCHLOROQUINE SULFATE, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-07-032681510511
103a047f49-ccb5-4cb6-b0d6-8abfa9c39f2e (view SPL)HYDROXYCHLOROQUINE SULFATE TABLETS, USP Rx Only Rev. 09/09prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2010-08-057001432128
113ce83016-a5fc-71cf-92df-b8194f6b525d (view SPL)Hydroxychloroquine Sulfate Tablets, USP 200 mg*prescriptionHuman PrescriptionAvkare, Inc.2015-02-203422910318
126016af90-6311-4f35-bfc3-ce49c105ba4f (view SPL)HYDROXYCHLOROQUINE SULFATE, USPprescriptionHuman PrescriptionPrasco Laboratories2015-06-045669930057
13631ed616-f23c-43c9-b63b-f53707c077cb (view SPL)PLAQUENILHYDROXYCHLOROQUINE SULFATE, USPprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-07-031249870562
146971241c-8323-456e-91a4-a404a9e100de (view SPL)Hydroxychloroquine sulfate tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-026551542074
1571a8ea7d-e71d-4b71-871e-b592dd7ad047 (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-09-272663360555
16805a1acd-2e0d-48f1-af6b-0e5d8e06c228 (view SPL)Hydroxychloroquine sulfate tablets, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, manufacture2015-06-183683820096
1788bd448d-bac7-4839-816a-8b800d7705c4 (view SPL)HYDROXYCHLOROQUINE SULFATEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-03-132619190132
188a99dbe0-2055-4513-b182-0416ceecd5f1 (view SPL)Hydroxychloroquine Sulfate Tablets USPRx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-101433530794
199d22f0a8-170b-4c3e-8c2e-a5cf64b9958b (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionSandoz Inc2014-09-2410007811407
20a2d7be5a-98ee-4292-8715-46573dbe1c5b (view SPL)Hydroxychloroquine sulfate tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-152680840269
21adf36d25-d86e-4d2d-b90c-e29f1394667d (view SPL)HydroxychloroquineSulfate Tablets USP Revised: July 2012 Rx only 14445-2prescriptionHuman PrescriptionWatson Laboratories, Inc.2013-06-034005910698
22b47e12d3-0395-4462-b856-2ecb033f11e6 (view SPL)Hydroxychloroquine sulfate tablets, USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2015-11-121637390777
23b5869e45-27fc-4f33-80db-4a509b8256c1 (view SPL)HydroxychloroquineSulfate Tablets, USPprescriptionHuman PrescriptionSandoz Inc2012-01-2312007811407
24c293257e-ecd1-4c41-994e-0fe15dee41d2 (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-041332610933
25d5a1c868-b92f-4386-b8f9-8719dd785954 (view SPL)Hydroxychloroquine Sulfate Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-072548683821
26ed80a489-672a-406f-b623-ee78ec150bed (view SPL)HYDROXYCHLOROQUINE SULFATE TABLETS, USP Rx Only Rev. 09/09prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290700
27ff0c9d83-6d86-4d22-939b-a838bffbcfd0 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-08-214003780373

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