Mupirocin Topical Ointment

Brand(s)
Bactroban, Centany
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-03-25)
Oldest Current Product
2000-04-07
License(s)
NDA, ANDA
RxNORM
TOPICAL OINTMENT\MUPIROCIN
FDAOB
TOPICAL\OINTMENT\MUPIROCIN
SPL Active
TOPICAL\OINTMENT\MUPIROCIN
SPL Moiety
TOPICAL\OINTMENT\MUPIROCIN

product(s) by strength(s)

mupirocin 0.02 mg/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000291525BactrobanNDAGlaxosmithkline Llc2000-04-07MUPIROCINTOPICALOINTMENTNDA0505916dd5868f-0bc2-48c8-238b-e857f5bd812f
2435380300CentanyNDAMedimetriks Pharmaceuticals Inc2009-02-26MUPIROCINTOPICALOINTMENTNDA05078890cfa2dc-3904-4bd3-b951-dcdb141883bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931010ANDATeva Pharmaceuticals Usa Inc2003-11-07MUPIROCINTOPICALOINTMENTANDA065085a543797a-2c1c-4ea3-bd6c-227a784f92d9
2001680352ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2005-11-30MUPIROCINTOPICALOINTMENTANDA065192c36cd006-08ba-4b3e-b012-4f31c10bd001
3458020112ANDAPerrigo New York Inc2009-10-30MUPIROCINTOPICALOINTMENTANDA065123e9b61f01-3c67-42a4-a62b-10f1d1343190
4516721312ANDATaro Pharmaceuticals U.S.A., Inc.2005-09-23MUPIROCINTOPICALOINTMENTANDA065170900bb675-2f03-47e3-854e-257ec4831332
5684620180ANDAGlenmark Generics Inc., Usa2011-06-08MUPIROCINTOPICALOINTMENTANDA090480ff7428fb-9ce9-4743-b58c-01a05424a57a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900158ANDAStat Rx Usa Llc2003-11-07MUPIROCINTOPICALOINTMENT458020112ANDA065123dc6c7600-454b-449f-af1c-ff1a8e1b8109
2216950188ANDARebel Distributors Corp2005-11-30MUPIROCINTOPICALOINTMENT001680352ANDA065192a76947bd-0430-4d79-b4c1-9d1746bc7f84
3422540137ANDARebel Distributors Corp2011-01-11MUPIROCINTOPICALOINTMENT000931010ANDA065085323bcad0-1e11-4946-a151-1a33557f0bfb
4422540229ANDARebel Distributors Corp2009-10-30MUPIROCINTOPICALOINTMENT458020112ANDA065123ed49fb2a-05f6-4df5-9c75-30df41a5aae1
5458650722ANDAMedsource Pharmaceuticals2003-11-07MUPIROCINTOPICALOINTMENT000931010ANDA0650851fc12db9-6580-509b-e054-00144ff88e88
6504360025ANDAUnit Dose Services2005-11-30MUPIROCINTOPICALOINTMENT001680352ANDA065192f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c
7504360112ANDAUnit Dose Services2009-10-30MUPIROCINTOPICALOINTMENT458020112ANDA065123ed60d758-dbce-4963-a378-6c8201c3e66f
8504361010ANDAUnit Dose Services2003-11-07MUPIROCINTOPICALOINTMENT000931010ANDA06508571c82fb9-a374-49f8-97e5-a3ace5c42b05
9521250239ANDARemedyrepack Inc.2013-06-12, 2013-11-22MUPIROCINTOPICALOINTMENT458020112ANDA0651233bf9190d-5d71-4d53-924c-8b00147f7338, 9bc11485-36d7-4824-9385-c43b10a39bf8
10521250545ANDARemedyrepack Inc.2013-11-22, 2014-01-09MUPIROCINTOPICALOINTMENT000931010ANDA0650854a742f4f-ec58-499c-aa76-75d98f503554, 5cbcde0a-4cd4-43e4-9f5f-912116e3aa1c
11529590743ANDAH.J. Harkins Company, Inc.2009-10-30MUPIROCINTOPICALOINTMENT458020112ANDA0651236a0b39c0-c207-4efc-ac2c-07506ad796df
12548684958ANDAPhysicians Total Care, Inc.2003-12-05MUPIROCINTOPICALOINTMENT001680352ANDA065192e2ddaea4-d914-4bc7-8913-351e7bf2e2f7
13581189932ANDAClinical Solutions Wholesale2005-09-23MUPIROCINTOPICALOINTMENT516721312ANDA06517015017193-2692-4285-8d08-0fa65d649fac
14619190158ANDADirect Rx2014-01-01MUPIROCINTOPICALOINTMENT000931010ANDA065085f88eea1a-2ba1-48bf-96c8-d96d18752aaa
15619190203ANDADirect Rx2015-01-01MUPIROCINTOPICALOINTMENT458020112ANDA065123c1d0416b-4d94-4e00-bc53-1dca40afdf21
16619190407ANDADirect Rx2015-01-01MUPIROCINTOPICALOINTMENT684620180ANDA0904803c4accb1-749d-4b89-bec5-5b9b7ea9dd23
17631870015ANDAProficient Rx Lp2011-06-08MUPIROCINTOPICALOINTMENT684620180ANDA0904802777e4f2-2b8d-41f5-a96a-02dec8c7c3e0
18631870151ANDAProficient Rx Lp2005-09-23MUPIROCINTOPICALOINTMENT516721312ANDA065170d8766748-6b53-4673-a3ee-5cd8a4301647
19631870261ANDAProficient Rx Lp2009-10-30MUPIROCINTOPICALOINTMENT458020112ANDA06512397f8d67d-c422-4a26-9394-24a5ec9719d9
20631870525ANDAProficient Rx Lp2003-11-07MUPIROCINTOPICALOINTMENT000931010ANDA065085cbb18010-f3b5-4ed7-8c03-c9203f0e360e
21683870550ANDAKeltman Pharmaceuticals Inc.2009-06-22MUPIROCINTOPICALOINTMENT001680352ANDA065192c624575e-558c-4cfd-b1e0-c262ed11cff9
22687889152ANDAPreferred Pharmaceuticals, Inc.2005-09-23MUPIROCINTOPICALOINTMENT516721312ANDA0651702289900b-889b-4536-9ed0-3bddb20c9387
23687889891ANDAPreferred Pharmaceuticals, Inc.2014-02-14MUPIROCINTOPICALOINTMENT458020112ANDA0651232d97832e-c6c7-4a06-b83a-f8369c04f51e

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA065085MUPIROCINTEVA PHARMACEUTICALS USA INC2003-11-07ANDA065085_001
2ANDA065123MUPIROCINPERRIGO NEW YORK INC2003-11-07ANDA065123_001
3ANDA065170MUPIROCINTARO PHARMACEUTICALS USA INC2005-09-23ANDA065170_001
4ANDA065192MUPIROCINFOUGERA PHARMACEUTICALS INC2005-11-30ANDA065192_001
5ANDA090480MUPIROCINGLENMARK PHARMACEUTICALS INC USA2011-06-08ANDA090480_001
6NDA050591BACTROBANGLAXOSMITHKLINE1987-12-31NDA050591_001
7NDA050788CENTANYPERRIGO NEW YORK INC2002-12-04p6013657, SUBSTANCENDA050788_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065085_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseAB2003-11-07MUPIROCIN
2ANDA065123_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseAB2003-11-07MUPIROCIN
3ANDA065170_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseAB2005-09-23MUPIROCIN
4ANDA065192_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseAB2005-11-30MUPIROCIN
5ANDA090480_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseAB2011-06-08MUPIROCIN
6NDA050591_001RXMUPIROCIN (2%)TOPICALOINTMENTTrueAB1987-12-31BACTROBAN
7NDA050788_001RXMUPIROCIN (2%)TOPICALOINTMENTFalseBX2002-12-04CENTANY

patent(s)

#idexpiration dateapplication(s)
1p6013657 (view patent)2018-07-08NDA050788

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115017193-2692-4285-8d08-0fa65d649fac (view SPL)Mupirocin Ointment USP, 2%prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-251581189932
21fc12db9-6580-509b-e054-00144ff88e88 (view SPL)MUPIROCIN OINTMENT USP, 2% 1010 For Dermatologic Use Rx onlyprescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-141458650722
32289900b-889b-4536-9ed0-3bddb20c9387 (view SPL)Mupirocin Ointment USP, 2%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-03-032687889152
42777e4f2-2b8d-41f5-a96a-02dec8c7c3e0 (view SPL)Mupirocin Ointment USP, 2%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-301631870015
52d97832e-c6c7-4a06-b83a-f8369c04f51e (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-03-033687889891
6323bcad0-1e11-4946-a151-1a33557f0bfb (view SPL)MUPIROCIN OINTMENT USP, 2%1010For Dermatologic UseprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-291422540137
73240802f-358d-48bb-9761-64f19e76e931 (view SPL)CENTANY (mupirocin ointment, 2%)prescriptionHuman PrescriptionMedimetriks Pharmaceuticals IncMANUFACTURE2010-12-082435380310
83bf9190d-5d71-4d53-924c-8b00147f7338 (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-221521250239
93c4accb1-749d-4b89-bec5-5b9b7ea9dd23 (view SPL)MUPIROCINprescriptionHuman PrescriptionDirect Rxrepack2015-10-211619190407
104a742f4f-ec58-499c-aa76-75d98f503554 (view SPL)MUPIROCIN OINTMENT USP, 2%1010For Dermatologic UseprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-221521250545
115cbcde0a-4cd4-43e4-9f5f-912116e3aa1c (view SPL)MUPIROCIN OINTMENT USP, 2%1010For Dermatologic UseprescriptionHuman PrescriptionRemedyrepack Inc.2014-01-091521250545
126a0b39c0-c207-4efc-ac2c-07506ad796df (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-11-021529590743
136dd5868f-0bc2-48c8-238b-e857f5bd812f (view SPL)BACTROBAN Ointment (mupirocin ointment, 2%) For Dermatologic UseprescriptionHuman PrescriptionGlaxosmithkline Llc2015-03-2510000291525
1471c82fb9-a374-49f8-97e5-a3ace5c42b05 (view SPL)MUPIROCIN OINTMENT USP, 2% 1010 For Dermatologic Use Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2015-05-072504361010
15900bb675-2f03-47e3-854e-257ec4831332 (view SPL)Mupirocin Ointment USP, 2%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-05-124516721312
1690cfa2dc-3904-4bd3-b951-dcdb141883bf (view SPL)CENTANY (mupirocin ointment, 2%)prescriptionHuman PrescriptionMedimetriks Pharmaceuticals Inc2011-01-312435380300
1797f8d67d-c422-4a26-9394-24a5ec9719d9 (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-10-014631870261
189bc11485-36d7-4824-9385-c43b10a39bf8 (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-121521250239
19a543797a-2c1c-4ea3-bd6c-227a784f92d9 (view SPL)MUPIROCIN OINTMENT USP, 2%1010For Dermatologic UseRx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-076000931010
20a76947bd-0430-4d79-b4c1-9d1746bc7f84 (view SPL)MUPIROCIN OINTMENT USP, 2%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-061216950188
21c1d0416b-4d94-4e00-bc53-1dca40afdf21 (view SPL)MUPIROCINprescriptionHuman PrescriptionDirect Rxrepack2015-10-261619190203
22c36cd006-08ba-4b3e-b012-4f31c10bd001 (view SPL)MUPIROCIN OINTMENT USP, 2%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-09-155001680352
23c624575e-558c-4cfd-b1e0-c262ed11cff9 (view SPL)MUPIROCIN OINTMENT USP, 2%prescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.relabel, repack2011-06-071683870550
24cbb18010-f3b5-4ed7-8c03-c9203f0e360e (view SPL)MUPIROCIN OINTMENT USP, 2% 1010 For Dermatologic Use Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870525
25d8766748-6b53-4673-a3ee-5cd8a4301647 (view SPL)Mupirocin Ointment USP, 2%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-08-011631870151
26dc6c7600-454b-449f-af1c-ff1a8e1b8109 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-091165900158
27e2ddaea4-d914-4bc7-8913-351e7bf2e2f7 (view SPL)MUPIROCIN OINTMENT USP, 2%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-04-021548684958
28e9b61f01-3c67-42a4-a62b-10f1d1343190 (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionPerrigo New York Inc2014-01-133458020112
29ed49fb2a-05f6-4df5-9c75-30df41a5aae1 (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-05-291422540229
30ed60d758-dbce-4963-a378-6c8201c3e66f (view SPL)MUPIROCINOINTMENT USP, 2%prescriptionHuman PrescriptionUnit Dose ServicesREPACK2014-01-132504360112
31f88eea1a-2ba1-48bf-96c8-d96d18752aaa (view SPL)MUPIROCINprescriptionHuman PrescriptionDirect Rxrelabel2014-04-011619190158
32f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c (view SPL)MUPIROCIN OINTMENT USP, 2%prescriptionHuman PrescriptionUnit Dose ServicesREPACK2009-04-022504360025
33ff7428fb-9ce9-4743-b58c-01a05424a57a (view SPL)MUPIROCIN Ointment USP, 2%prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-05-056684620180

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