trimethobenzamide Oral Capsule

Brand(s)
Tigan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2014-06-04)
Oldest Current Product
2001-12-13
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TRIMETHOBENZAMIDE
FDAOB
ORAL\CAPSULE\TRIMETHOBENZAMIDE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\TRIMETHOBENZAMIDE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\TRIMETHOBENZAMIDE

product(s) by strength(s)

trimethobenzamide hydrochloride 300 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1615700079TiganNDAPfizer Laboratories Div Pfizer Inc2001-12-13TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULENDA01753105845d9b-a9ce-42c8-8598-48a938d9ac38

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433860660ANDAGavis Pharmaceuticals, Llc2011-01-17TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULEANDA076546c18073be-d52a-4347-a8d1-6be11bcb7824
2534890376ANDAMutual Pharmaceutical Company, Inc.2003-08-28TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULEANDA076570588e2253-cef6-4a97-b5a0-01eb11ab44d6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950448ANDARebel Distributors Corp2003-08-28TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE534890376ANDA07657043a47783-c605-49eb-a4fa-8524e75e69de
2353560473ANDALake Erie Medical Dba Quality Care Products Llc2010-07-13TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE534890376ANDA0765701167c0dc-db58-4523-b6cb-5a162ea1f5a3
3493490496ANDARemedyrepack Inc.2011-08-18, 2013-07-25, 2013-09-27, 2013-12-31TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE534890376ANDA07657041dd043c-255b-4482-bc8d-c526106279d6, 760afbcd-bc81-4595-82c8-ec1cbd7c2b08, c60ee6e8-cdbe-45fe-8a03-e54621b0a238, ca994b65-0673-4346-b9de-eb68a38943fc
4521250143TiganNDARemedyrepack Inc.2013-03-11, 2013-03-12, 2013-05-20TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE615700079NDA01753101a95f6d-f7d6-4ed1-a262-3c5848915252, 1e82ad4d-5943-4007-b0fd-0e3e7e4e6847, 987a885a-4d64-4af2-8661-19f66575dab6
5548685741ANDAPhysicians Total Care, Inc.2007-01-05TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE53489037601ANDA0765701e2348ed-b72b-4779-9207-faa3ce303487
6636293685ANDABryant Ranch Prepack2003-08-28TRIMETHOBENZAMIDE HYDROCHLORIDEORALCAPSULE534890376ANDA07657034cd4cf0-5990-48b3-10ec-206e2e33f7fe

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076546TRIMETHOBENZAMIDE HYDROCHLORIDEGAVIS PHARMACEUTICALS LLC2003-08-20ANDA076546_001
2ANDA076570TRIMETHOBENZAMIDE HYDROCHLORIDEMUTUAL PHARMACAL CO2003-08-28ANDA076570_001
3NDA017531TIGANKING PHARMACEUTICALS INC2001-12-13NDA017531_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076546_001RXTRIMETHOBENZAMIDE HYDROCHLORIDE (300MG)ORALCAPSULEFalseAB2003-08-20TRIMETHOBENZAMIDE HYDROCHLORIDE
2ANDA076570_001RXTRIMETHOBENZAMIDE HYDROCHLORIDE (300MG)ORALCAPSULEFalseAB2003-08-28TRIMETHOBENZAMIDE HYDROCHLORIDE
3NDA017531_006RXTRIMETHOBENZAMIDE HYDROCHLORIDE (300MG)ORALCAPSULETrueAB2001-12-13TIGAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101a95f6d-f7d6-4ed1-a262-3c5848915252 (view SPL)Tigan(trimethobenzamide hydrochloride)CapsulesprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-111521250143
205845d9b-a9ce-42c8-8598-48a938d9ac38 (view SPL)Tigan(trimethobenzamide hydrochloride)CapsulesprescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, LABEL, MANUFACTURE, PACK2014-06-043615700079
31167c0dc-db58-4523-b6cb-5a162ea1f5a3 (view SPL)Trimethobenzamide HCl 300 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2010-07-13337353560473
41e2348ed-b72b-4779-9207-faa3ce303487 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-241548685741
51e82ad4d-5943-4007-b0fd-0e3e7e4e6847 (view SPL)Tigan(trimethobenzamide hydrochloride)CapsulesprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-201521250143
634cd4cf0-5990-48b3-10ec-206e2e33f7fe (view SPL)TRIMETHOBENZAMIDEprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-173636293685
741dd043c-255b-4482-bc8d-c526106279d6 (view SPL)TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-272493490496
843a47783-c605-49eb-a4fa-8524e75e69de (view SPL)TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-12-011216950448
9588e2253-cef6-4a97-b5a0-01eb11ab44d6 (view SPL)TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-02-056534890376
10760afbcd-bc81-4595-82c8-ec1cbd7c2b08 (view SPL)TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-311493490496
11987a885a-4d64-4af2-8661-19f66575dab6 (view SPL)Tigan(trimethobenzamide hydrochloride)CapsulesprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-121521250143
12c18073be-d52a-4347-a8d1-6be11bcb7824 (view SPL)Trimethobenzamide Hydrochloride Capsules, USP Gavis Pharmaceuticals, LLC Rx onlyprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-10-182433860660
13c60ee6e8-cdbe-45fe-8a03-e54621b0a238 (view SPL)TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-253493490496
14ca994b65-0673-4346-b9de-eb68a38943fc (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-181493490496

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