Lidocaine Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Avkare, Inc. (2015-09-25)
Oldest Current Product
1972-06-30
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\LIDOCAINE
FDAOB
TOPICAL\OINTMENT\LIDOCAINE
SPL Active
TOPICAL\OINTMENT\LIDOCAINE
SPL Moiety
TOPICAL\OINTMENT\LIDOCAINE

product(s) by strength(s)

lidocaine 0.05 mg/mg topical ointment

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1422910378Avkare, Inc.LIDOCAINETOPICALOINTMENT42abc81b-668f-7ec4-f37f-bdc5ac43465d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680204ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1972-06-30LIDOCAINETOPICALOINTMENTANDA08019888ca9cba-0c4a-482f-b502-ceefdb1bfbcd
2003620221ANDASeptodont Inc.2015-05-20LIDOCAINETOPICALOINTMENTANDA04091182a4c16f-d47e-479f-8f85-7d1be6fc2318
3458610061ANDAPharmaceutica North America, Inc2015-08-13LIDOCAINETOPICALOINTMENTANDA08672422693fd1-f831-49af-a389-26504e5db2eb
4503830933ANDAHi-Tech Pharmacal Co., Inc.2012-03-12LIDOCAINETOPICALOINTMENTANDA040911f130a654-ee3b-4daa-8dc6-8f514edf75a1
5516723008ANDATaro Pharmaceuticals U.S.A., Inc.1981-08-17LIDOCAINETOPICALOINTMENTANDA0867245eb2c62f-5352-41d7-bd66-c65b1988a9ab
6516723020ANDATaro Pharmaceuticals U.S.A., Inc.2013-03-25LIDOCAINETOPICALOINTMENTANDA086724ae758020-a508-4a2e-8164-e6c324e826a3
7575390221ANDANovocol Inc.2011-10-01LIDOCAINETOPICALOINTMENTANDA040911c66b3509-c670-4124-86ac-da313958aabd
8651620918ANDAAmneal Pharmaceuticals2015-08-10LIDOCAINETOPICALOINTMENTANDA206297d1509740-f9f1-44e3-8fde-51d8683fcd87
9693290400ANDAPatchwerx Labs, Inc.2012-03-12ANDA0409111f498517-a3e6-00d7-e054-00144ff88e88, 1f49b979-a41f-08fd-e054-00144ff88e88

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950826ANDARebel Distributors Corp1972-06-30LIDOCAINETOPICALOINTMENT001680204ANDA080198a1e2c14f-0682-4b19-9159-de0aca1960c6
2332610564ANDAAidarex Pharmaceuticals Llc1972-06-30LIDOCAINETOPICALOINTMENT001680204ANDA080198670287ac-9d8d-4514-b433-4adcca2d915a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040911LIDOCAINENOVOCOL INC2011-05-23ANDA040911_001
2ANDA080198LIDOCAINEE FOUGERA DIV ALTANA INCANDA080198_001
3ANDA080210LIDOCAINETrueBELMORA LLCANDA080210_001
4ANDA084944ALPHACAINETrueCARLISLE LABORATORIES INCANDA084944_001
5ANDA084946ALPHACAINETrueCARLISLE LABORATORIES INCANDA084946_001
6ANDA084947ALPHACAINETrueCARLISLE LABORATORIES INCANDA084947_001
7ANDA086724LIDOCAINETARO PHARMACEUTICALS USA INCANDA086724_001
8ANDA206297LIDOCAINEAMNEAL PHARMACEUTICALS2015-08-07ANDA206297_001
9NDA008048XYLOCAINETrueASTRAZENECA LPNDA008048_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040911_001RXLIDOCAINE (5%)TOPICALOINTMENTFalseAT2011-05-23LIDOCAINE
2ANDA080198_001RXLIDOCAINE (5%)TOPICALOINTMENTTrueATLIDOCAINE
3ANDA080210_001discontinuedLIDOCAINE (5%)TOPICALOINTMENTFalseLIDOCAINE
4ANDA084944_001discontinuedLIDOCAINE (5%)TOPICALOINTMENTFalseALPHACAINE
5ANDA084946_001discontinuedLIDOCAINE (5%)TOPICALOINTMENTFalseALPHACAINE
6ANDA084947_001discontinuedLIDOCAINE (5%)TOPICALOINTMENTFalseALPHACAINE
7ANDA086724_001RXLIDOCAINE (5%)TOPICALOINTMENTFalseATLIDOCAINE
8ANDA206297_001RXLIDOCAINE (5%)TOPICALOINTMENTFalseAT2015-08-07LIDOCAINE
9NDA008048_001discontinuedLIDOCAINE (5%)TOPICALOINTMENTFalseXYLOCAINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11f498517-a3e6-00d7-e054-00144ff88e88 (view SPL)LidoRxKitprescriptionHuman PrescriptionPatchwerx Labs, Inc.2015-09-071693290400
21f49b979-a41f-08fd-e054-00144ff88e88 (view SPL)LidoRxKitprescriptionHuman PrescriptionPatchwerx Labs, Inc.2015-09-092693290400
322693fd1-f831-49af-a389-26504e5db2eb (view SPL)Lidocaine Ointment USP, 5%prescriptionHuman PrescriptionPharmaceutica North America, Inc2015-08-131458610061
442abc81b-668f-7ec4-f37f-bdc5ac43465d (view SPL)LidocaineOintment USP, 5%prescriptionHuman PrescriptionAvkare, Inc.2015-09-252422910378
55eb2c62f-5352-41d7-bd66-c65b1988a9ab (view SPL)LIDOCAINE OINTMENT USP, 5% (Spearmint Flavored)prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-293516723008
6670287ac-9d8d-4514-b433-4adcca2d915a (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-091332610564
782a4c16f-d47e-479f-8f85-7d1be6fc2318 (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionSeptodont Inc.label, manufacture2015-05-051003620221
888ca9cba-0c4a-482f-b502-ceefdb1bfbcd (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-08-224001680204
9a1e2c14f-0682-4b19-9159-de0aca1960c6 (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-011216950826
10ae758020-a508-4a2e-8164-e6c324e826a3 (view SPL)Lidocaine Ointment USP, 5%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-04-202516723020
11c66b3509-c670-4124-86ac-da313958aabd (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionNovocol Inc.LABEL, MANUFACTURE2011-12-091575390221
12d1509740-f9f1-44e3-8fde-51d8683fcd87 (view SPL)Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx OnlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-08-135651620918
13f130a654-ee3b-4daa-8dc6-8f514edf75a1 (view SPL)LIDOCAINE OINTMENT USP, 5%prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.LABEL, MANUFACTURE2012-03-232503830933

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