modafinil Oral Tablet

Brand(s)
Provigil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Citron Pharma Llc (2015-10-16)
Oldest Current Product
1998-12-24
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\MODAFINIL
FDAOB
ORAL\TABLET\MODAFINIL
SPL Active
ORAL\TABLET\MODAFINIL
SPL Moiety
ORAL\TABLET\MODAFINIL

product(s) by strength(s)

modafinil 100 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1420430160Orchidpharma IncMODAFINILORALTABLET01f6690c-1410-42ad-8eb3-e7df32eab3ba

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785573ANDAMylan Pharmaceuticals Inc.2012-08-10MODAFINILORALTABLETANDA076594f3b3097f-80b8-4410-af21-dcdea144e3c3
2005913499ANDAWatson Laboratories, Inc.2013-04-03MODAFINILORALTABLETANDA0767155bc33938-2717-471b-b066-c6c67317d4e0
3006034661ANDAQualitest Pharmaceuticals2013-01-29MODAFINILORALTABLETANDA2027002cc86071-bc4b-446c-9b65-37b1ff43770f
4498840534NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2012-04-06MODAFINILORALTABLETNDA0207170c634b7a-cce6-4c3d-9c49-63593755f49c
5507420152ANDAIngenus Pharmaceuticals, Llc2014-04-01MODAFINILORALTABLETANDA0789633107e636-ad6f-4125-a90d-f16511b86f8d
6552530801NDA AUTHORIZED GENERICCima Labs Inc.2012-03-29MODAFINILORALTABLETNDA0207179f3b0bd2-72a3-411f-aeec-b533373f1a97
7572370154ANDACitron Pharma Llc2012-09-27MODAFINILORALTABLETANDA2025664b63aac6-4385-44a3-8390-cdbb0b4b5fe0
8591150070ANDAHikma Pharmaceutical2008-04-04MODAFINILORALTABLETANDA0905433bf643a3-ca5d-43bd-9b83-865fa5d4eb08
9605052526ANDAApotex Corp2014-02-03MODAFINILORALTABLETANDA077667944daf47-49a6-93ca-e348-4a0f1b6d937e
10658620601ANDAAurobindo Pharma Limited2012-09-27MODAFINILORALTABLETANDA202566f51ca007-3955-4540-a88a-0ddae8d8e8ab

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046423ANDAMajor2013-04-03MODAFINILORALTABLET005913499ANDA0767155e6fb6ac-ba3e-4002-9521-07193b7b8255
2216950234ProvigilNDARebel Distributors Corp2005-06-03MODAFINILORALTABLET634590101NDA0207178b79d52e-e6e5-4aaf-8835-242c72d6ee38
3422910599ANDAAvkare, Inc.2014-02-24MODAFINILORALTABLET005913499ANDA0767157207a87d-1bca-b7b5-6df2-605812b7c295
4510790561ANDAMylan Institutional Inc.2012-09-06MODAFINILORALTABLET003785573ANDA0765941f89a085-c937-4e77-9e90-fb04536cb460
5548684492ProvigilNDAPhysicians Total Care, Inc.2005-06-03MODAFINILORALTABLET634590101NDA0207175053c113-69df-4ade-a186-02bc054c23d1
6551540975ProvigilNDACardinal Health1998-12-24MODAFINILORALTABLET634590101NDA02071791d2f78d-8501-45d8-b6ff-33b393f75079
7604290581ANDAGolden State Medical Supply, Inc.2014-02-03MODAFINILORALTABLET605052526ANDA077667120cd2f0-7021-4036-a4c3-2e06f0252d74
8636293388ProvigilNDABryant Ranch Prepack1998-12-24MODAFINILORALTABLET634590101NDA0207172b57c771-0041-4226-999c-7a788cf73552
9680840621ANDAAmerican Health Packaging2014-04-01MODAFINILORALTABLET658620601ANDA202566928a3ab6-b53c-4924-882c-9f2f49aba0f1

modafinil 200 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1420430161Orchidpharma IncMODAFINILORALTABLET01f6690c-1410-42ad-8eb3-e7df32eab3ba

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785575ANDAMylan Pharmaceuticals Inc.2012-08-10MODAFINILORALTABLETANDA076594f3b3097f-80b8-4410-af21-dcdea144e3c3
2005913500ANDAWatson Laboratories, Inc.2013-04-03MODAFINILORALTABLETANDA0767155bc33938-2717-471b-b066-c6c67317d4e0
3006034662ANDAQualitest Pharmaceuticals2013-01-29MODAFINILORALTABLETANDA2027002cc86071-bc4b-446c-9b65-37b1ff43770f
4498840535NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2012-04-06MODAFINILORALTABLETNDA0207170c634b7a-cce6-4c3d-9c49-63593755f49c
5507420153ANDAIngenus Pharmaceuticals, Llc2014-04-01MODAFINILORALTABLETANDA0789633107e636-ad6f-4125-a90d-f16511b86f8d
6552530802NDA AUTHORIZED GENERICCima Labs Inc.2012-03-29MODAFINILORALTABLETNDA0207179f3b0bd2-72a3-411f-aeec-b533373f1a97
7572370155ANDACitron Pharma Llc2012-09-27MODAFINILORALTABLETANDA2025664b63aac6-4385-44a3-8390-cdbb0b4b5fe0
8591150069ANDAHikma Pharmaceutical2008-04-04MODAFINILORALTABLETANDA0905433bf643a3-ca5d-43bd-9b83-865fa5d4eb08
9605052527ANDAApotex Corp2014-02-03MODAFINILORALTABLETANDA077667944daf47-49a6-93ca-e348-4a0f1b6d937e
10658620602ANDAAurobindo Pharma Limited2012-09-27MODAFINILORALTABLETANDA202566f51ca007-3955-4540-a88a-0ddae8d8e8ab

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046424ANDAMajor2013-04-03MODAFINILORALTABLET005913500ANDA0767155e6fb6ac-ba3e-4002-9521-07193b7b8255
2216950235ProvigilNDARebel Distributors Corp2004-01-19MODAFINILORALTABLET634590201NDA0207178b79d52e-e6e5-4aaf-8835-242c72d6ee38
3353560372ProvigilNDALake Erie Medical Dba Quality Care Products Llc2011-07-20MODAFINILORALTABLET634590201NDA020717a85d5629-748d-4920-b0d6-3012a0ace1a3
4422910600ANDAAvkare, Inc.2014-02-24MODAFINILORALTABLET005913500ANDA0767157207a87d-1bca-b7b5-6df2-605812b7c295
5425490678NDA AUTHORIZED GENERICStat Rx Usa Llc2012-04-06MODAFINILORALTABLET498840535NDA020717eba3a655-074b-46b3-88cf-3e6b2c0c8b15
6433530831ANDAAphena Pharma Solutions - Tennessee, Llc2012-08-10MODAFINILORALTABLET003785575ANDA076594514d242d-48c9-4162-a85a-a433b41107ac
7433530925NDA AUTHORIZED GENERICAphena Pharma Solutions - Tennessee, Llc2012-03-29MODAFINILORALTABLET552530802NDA020717cad4201c-133c-4a61-9d93-3c5e51695430
8504360201ProvigilNDAUnit Dose Services1998-12-24MODAFINILORALTABLET634590201NDA020717fd75a8a7-a8ab-4141-9af9-989a220b9c19
9510790562ANDAMylan Institutional Inc.2012-09-06MODAFINILORALTABLET003785575ANDA0765941f89a085-c937-4e77-9e90-fb04536cb460
10548684897ProvigilNDAPhysicians Total Care, Inc.2004-01-19MODAFINILORALTABLET634590201NDA0207175053c113-69df-4ade-a186-02bc054c23d1
11604290582ANDAGolden State Medical Supply, Inc.2014-02-03MODAFINILORALTABLET605052527ANDA077667120cd2f0-7021-4036-a4c3-2e06f0252d74
12636291611ProvigilNDABryant Ranch Prepack1998-12-24MODAFINILORALTABLET634590201NDA020717108a276f-b07b-d94f-4488-c3e3b6683d4f
13636294998ANDABryant Ranch Prepack2013-04-03MODAFINILORALTABLET005913500ANDA076715299a585f-fed1-49f2-8750-657b1c5e0c70
14680840721ANDAAmerican Health Packaging2014-04-01MODAFINILORALTABLET658620602ANDA202566928a3ab6-b53c-4924-882c-9f2f49aba0f1
15682587981NDA AUTHORIZED GENERICDispensing Solutions, Inc.2012-03-29MODAFINILORALTABLET552530802NDA020717ca740635-df30-46af-9202-55af9204f381

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076594MODAFINILMYLAN PHARMACEUTICALS INC2012-07-16ANDA076594_001, ANDA076594_002
2ANDA076715MODAFINILCARLSBAD TECHNOLOGY INC2012-11-01ANDA076715_001, ANDA076715_002
3ANDA077667MODAFINILAPOTEX INC2014-02-03ANDA077667_001, ANDA077667_002
4ANDA078963MODAFINILORCHID HEALTHCARE2012-09-26ANDA078963_001, ANDA078963_002
5ANDA090543MODAFINILHIKMA PHARMACEUTICALS2012-09-26ANDA090543_001, ANDA090543_002
6ANDA202566MODAFINILAUROBINDO PHARMA LTD2012-09-27ANDA202566_001, ANDA202566_002
7ANDA202700MODAFINILALEMBIC LTD2012-10-18ANDA202700_001, ANDA202700_002
8NDA020717PROVIGILCEPHALON INC1998-12-24p7297346, SUBSTANCE
pRE37516, IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY
NDA020717_001, NDA020717_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076594_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-07-16MODAFINIL
2ANDA076594_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-07-16MODAFINIL
3ANDA076715_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-11-01MODAFINIL
4ANDA076715_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-11-01MODAFINIL
5ANDA077667_001RXMODAFINIL (100MG)ORALTABLETFalseAB2014-02-03MODAFINIL
6ANDA077667_002RXMODAFINIL (200MG)ORALTABLETFalseAB2014-02-03MODAFINIL
7ANDA078963_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-09-26MODAFINIL
8ANDA078963_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-09-26MODAFINIL
9ANDA090543_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-09-26MODAFINIL
10ANDA090543_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-09-26MODAFINIL
11ANDA202566_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-09-27MODAFINIL
12ANDA202566_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-09-27MODAFINIL
13ANDA202700_001RXMODAFINIL (100MG)ORALTABLETFalseAB2012-10-18MODAFINIL
14ANDA202700_002RXMODAFINIL (200MG)ORALTABLETFalseAB2012-10-18MODAFINIL
15NDA020717_001RXMODAFINIL (100MG)ORALTABLETFalseAB1998-12-24PROVIGIL
16NDA020717_002RXMODAFINIL (200MG)ORALTABLETTrueAB1998-12-24PROVIGIL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7297346 (view patent)2023-11-29NDA020717, NDA021875armodafinil Oral Tablet
2pRE37516 (view patent)2014-10-06NDA020717, NDA021875armodafinil Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101f6690c-1410-42ad-8eb3-e7df32eab3ba (view SPL)These highlights do not include all the information needed to useModafinil Tablets safely and effectively. See full prescribing information for Modafinil Tablets. Modafinil Tablets USP, for oral use, C-IVInitial U.S. Approval: 1998prescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2015-09-2810420430160, 420430161
20c634b7a-cce6-4c3d-9c49-63593755f49c (view SPL)These highlights do not include all the information needed to use modafinil safely and effectively. See full prescribing information for modafinil. Modafinil tablets, for oral use, C-IV Initial U.S. Approval: 1998prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2015-03-173498840534, 498840535
3108a276f-b07b-d94f-4488-c3e3b6683d4f (view SPL)PROVIGILprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636291611
4120cd2f0-7021-4036-a4c3-2e06f0252d74 (view SPL)Modafinil Tablets 100 mg and 200 mg CIVprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-311604290581, 604290582
51f89a085-c937-4e77-9e90-fb04536cb460 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-08-023510790561, 510790562
6299a585f-fed1-49f2-8750-657b1c5e0c70 (view SPL)Modafinil Tablets, USPRevised: March 2012Rx Only2151863prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-11-121001636294998
72b57c771-0041-4226-999c-7a788cf73552 (view SPL)PROVIGIL (modafinil) Tablets [C-IV]prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-241000636293388
82cc86071-bc4b-446c-9b65-37b1ff43770f (view SPL)Modafinil Tablets, USP [C-IV]Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2013-01-295006034661, 006034662
93107e636-ad6f-4125-a90d-f16511b86f8d (view SPL)These highlights do not include all the information needed to useModafinil Tablets safely and effectively. See full prescribing information for Modafinil Tablets. Modafinil Tablets USP, for oral use, C-IVInitial U.S. Approval: 1998prescriptionHuman PrescriptionIngenus Pharmaceuticals, Llcanalysis, label, manufacture, pack2015-02-182507420152, 507420153
103bf643a3-ca5d-43bd-9b83-865fa5d4eb08 (view SPL)Modafinil Tablets USPprescriptionHuman PrescriptionHikma Pharmaceutical2014-09-235591150069, 591150070
114b63aac6-4385-44a3-8390-cdbb0b4b5fe0 (view SPL)These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIVInitial U.S. Approval: 1998prescriptionHuman PrescriptionCitron Pharma Llc2015-10-161572370154, 572370155
125053c113-69df-4ade-a186-02bc054c23d1 (view SPL)PROVIGIL (modafinil) Tablets [C-IV]prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-122548684492, 548684897
13514d242d-48c9-4162-a85a-a433b41107ac (view SPL)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-04-031433530831
145bc33938-2717-471b-b066-c6c67317d4e0 (view SPL)Modafinil Tablets, USPRevised: March 2012Rx Only2151863prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-03-017005913499, 005913500
155e6fb6ac-ba3e-4002-9521-07193b7b8255 (view SPL)Modafinil Tablets, USPRevised: March 2012Rx Only2151863prescriptionHuman PrescriptionMajor2015-11-181009046423, 009046424
167207a87d-1bca-b7b5-6df2-605812b7c295 (view SPL)Modafinil Tablets, USPprescriptionHuman PrescriptionAvkare, Inc.2015-02-032422910599, 422910600
178b79d52e-e6e5-4aaf-8835-242c72d6ee38 (view SPL)PROVIGIL (modafinil) Tablets [C-IV]prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-271216950234, 216950235
1891d2f78d-8501-45d8-b6ff-33b393f75079 (view SPL)PROVIGIL (modafinil) Tablets [C-IV]prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-162551540975
19928a3ab6-b53c-4924-882c-9f2f49aba0f1 (view SPL)Modafinil Tablets, USP (C-IV)prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-04-013680840621, 680840721
20944daf47-49a6-93ca-e348-4a0f1b6d937e (view SPL)These highlights do not include all the information needed to use MODAFINIL TABLETS, USP safely and effectively. See full prescribing information for MODAFINIL TABLETS, USP. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-07-0510605052526, 605052527
219f3b0bd2-72a3-411f-aeec-b533373f1a97 (view SPL)These highlights do not include all the information needed to use modafinil safely and effectively. See full prescribing information for modafinil. Modafinil tablets, for oral use, C-IV Initial U.S. Approval: 1998prescriptionHuman PrescriptionCima Labs Inc.2015-03-162552530801, 552530802
22a85d5629-748d-4920-b0d6-3012a0ace1a3 (view SPL)PROVIGIL (modafinil) Tablets [C-IV]prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2011-11-155056353560372
23ca740635-df30-46af-9202-55af9204f381 (view SPL)Modafinil TabletsprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-10-291682587981
24cad4201c-133c-4a61-9d93-3c5e51695430 (view SPL)Modafinil TabletsprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-181433530925
25e16c26ad-7bc2-d155-3a5d-da83ad6492c8 (view SPL)These highlights do not include all the information needed to use PROVIGIL safely and effectively. See full prescribing information for PROVIGIL. PROVIGIL (modafinil) tablets, for oral use, C-IV Initial U.S. Approval: 1998prescriptionHuman PrescriptionCephalon, Incorporated2015-01-287634590101, 634590201
26eba3a655-074b-46b3-88cf-3e6b2c0c8b15 (view SPL)Modafinil Tablets C-IV 200 mgprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-05-141425490678
27f3b3097f-80b8-4410-af21-dcdea144e3c3 (view SPL)These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets, USP for oral use CIV Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-237003785573, 003785575
28f51ca007-3955-4540-a88a-0ddae8d8e8ab (view SPL)These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIVInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-03-044658620601, 658620602
29fd75a8a7-a8ab-4141-9af9-989a220b9c19 (view SPL)PROVIGIL (modafinil) Tablets [C-IV] prescriptionHuman PrescriptionUnit Dose ServicesREPACK2008-04-142504360201

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