Mexiletine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-10-07)
Oldest Current Product
1995-06-05
License(s)
ANDA
RxNORM
ORAL CAPSULE\MEXILETINE
FDAOB
ORAL\CAPSULE\MEXILETINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\MEXILETINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\MEXILETINE

product(s) by strength(s)

mexiletine hydrochloride 150 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000938739ANDATeva Pharmaceuticals Usa Inc1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULEANDA074377693da40b-26d4-40d6-87d1-158e256f40ab

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910624ANDAAvkare, Inc.2013-07-09MEXILETINE HYDROCHLORIDEORALCAPSULE000938739ANDA074377c528aae3-ff51-b9e4-a401-4ef5910e4b43
2499990916ANDALake Erie Medical Dba Quality Care Products Llc2012-03-16MEXILETINE HYDROCHLORIDEORALCAPSULE000938739ANDA074377ca648488-4f8d-4d26-be4d-6a75fbb8b62c
3681512985ANDACarilion Materials Management1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULE000938739ANDA07437725b8c89e-450c-4a1d-9053-1eb97b868a98

mexiletine hydrochloride 200 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000938740ANDATeva Pharmaceuticals Usa Inc1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULEANDA074377693da40b-26d4-40d6-87d1-158e256f40ab

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910625ANDAAvkare, Inc.2013-07-09MEXILETINE HYDROCHLORIDEORALCAPSULE000938740ANDA074377c528aae3-ff51-b9e4-a401-4ef5910e4b43
2681512347ANDACarilion Materials Management1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULE000938740ANDA074377402b3836-89de-4468-8266-8910430d0053

mexiletine hydrochloride 250 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000938741ANDATeva Pharmaceuticals Usa Inc1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULEANDA074377693da40b-26d4-40d6-87d1-158e256f40ab

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910626ANDAAvkare, Inc.2013-07-09MEXILETINE HYDROCHLORIDEORALCAPSULE000938741ANDA074377c528aae3-ff51-b9e4-a401-4ef5910e4b43
2681512986ANDACarilion Materials Management1995-06-05MEXILETINE HYDROCHLORIDEORALCAPSULE000938741ANDA074377bb8c0b61-fcb1-4b51-9505-f1670693f00f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074377MEXILETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC1995-05-16ANDA074377_001, ANDA074377_002, ANDA074377_003
2ANDA074450MEXILETINE HYDROCHLORIDETrueIDT AUSTRALIA LTD1996-05-16ANDA074450_001, ANDA074450_002, ANDA074450_003
3ANDA074711MEXILETINE HYDROCHLORIDETrueWATSON LABORATORIES INC1997-02-26ANDA074711_001, ANDA074711_002, ANDA074711_003
4ANDA074865MEXILETINE HYDROCHLORIDETrueWATSON LABORATORIES INC1998-04-13ANDA074865_001, ANDA074865_002, ANDA074865_003
5NDA018873MEXITILTrueBOEHRINGER INGELHEIM1985-12-30NDA018873_002, NDA018873_003, NDA018873_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074377_001RXMEXILETINE HYDROCHLORIDE (150MG)ORALCAPSULEFalse1995-05-16MEXILETINE HYDROCHLORIDE
2ANDA074377_002RXMEXILETINE HYDROCHLORIDE (200MG)ORALCAPSULEFalse1995-05-16MEXILETINE HYDROCHLORIDE
3ANDA074377_003RXMEXILETINE HYDROCHLORIDE (250MG)ORALCAPSULETrue1995-05-16MEXILETINE HYDROCHLORIDE
4ANDA074450_001discontinuedMEXILETINE HYDROCHLORIDE (150MG)ORALCAPSULEFalse1996-05-16MEXILETINE HYDROCHLORIDE
5ANDA074450_002discontinuedMEXILETINE HYDROCHLORIDE (200MG)ORALCAPSULEFalse1996-05-16MEXILETINE HYDROCHLORIDE
6ANDA074450_003discontinuedMEXILETINE HYDROCHLORIDE (250MG)ORALCAPSULEFalse1996-05-16MEXILETINE HYDROCHLORIDE
7ANDA074711_001discontinuedMEXILETINE HYDROCHLORIDE (150MG)ORALCAPSULEFalse1997-02-26MEXILETINE HYDROCHLORIDE
8ANDA074711_002discontinuedMEXILETINE HYDROCHLORIDE (200MG)ORALCAPSULEFalse1997-02-26MEXILETINE HYDROCHLORIDE
9ANDA074711_003discontinuedMEXILETINE HYDROCHLORIDE (250MG)ORALCAPSULEFalse1997-02-26MEXILETINE HYDROCHLORIDE
10ANDA074865_001discontinuedMEXILETINE HYDROCHLORIDE (150MG)ORALCAPSULEFalse1998-04-13MEXILETINE HYDROCHLORIDE
11ANDA074865_002discontinuedMEXILETINE HYDROCHLORIDE (200MG)ORALCAPSULEFalse1998-04-13MEXILETINE HYDROCHLORIDE
12ANDA074865_003discontinuedMEXILETINE HYDROCHLORIDE (250MG)ORALCAPSULEFalse1998-04-13MEXILETINE HYDROCHLORIDE
13NDA018873_002discontinuedMEXILETINE HYDROCHLORIDE (150MG)ORALCAPSULEFalse1985-12-30MEXITIL
14NDA018873_003discontinuedMEXILETINE HYDROCHLORIDE (200MG)ORALCAPSULEFalse1985-12-30MEXITIL
15NDA018873_004discontinuedMEXILETINE HYDROCHLORIDE (250MG)ORALCAPSULEFalse1985-12-30MEXITIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
125b8c89e-450c-4a1d-9053-1eb97b868a98 (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USP 8739 8740 8741 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-06-062681512985
2402b3836-89de-4468-8266-8910430d0053 (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USP 8739 8740 8741 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-06-062681512347
3693da40b-26d4-40d6-87d1-158e256f40ab (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USP873987408741Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-076000938739, 000938740, 000938741
4bb8c0b61-fcb1-4b51-9505-f1670693f00f (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USP 8739 8740 8741 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-06-062681512986
5c528aae3-ff51-b9e4-a401-4ef5910e4b43 (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionAvkare, Inc.2013-07-092422910624, 422910625, 422910626
6ca648488-4f8d-4d26-be4d-6a75fbb8b62c (view SPL)MEXILETINE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-04-163749499990916

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