Methenamine Oral Tablet

Brand(s)
Hiprex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bryant Ranch Prepack (2014-05-08)
Oldest Current Product
1976-09-09
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
ORAL TABLET\METHENAMINE
FDAOB
ORAL\TABLET\METHENAMINE HIPPURATE
SPL Active
ORAL\TABLET, FILM COATED\METHENAMINE MANDELATE
ORAL\TABLET\METHENAMINE HIPPURATE
ORAL\TABLET\METHENAMINE MANDELATE
SPL Moiety
ORAL\TABLET, FILM COATED\METHENAMINE
ORAL\TABLET\METHENAMINE
ORAL\TABLET\METHENAMINE HIPPURATE

product(s) by strength(s)

methenamine hippurate 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680277HiprexNDASanofi-Aventis U.S. Llc1976-09-09METHENAMINE HIPPURATEORALTABLETNDA0176817488ad5c-376d-47a2-8c23-47eff94547fb
2139250107UNAPPROVED DRUG OTHER MARKETING CATEGORYSeton Pharmaceuticals2010-02-01METHENAMINE MANDELATEORALTABLET, FILM COATEDd21a1fdb-7111-4038-975f-f93de44d63a7
3431990020NDACounty Line Pharmaceuticals, Llc2010-05-03METHENAMINE HIPPURATEORALTABLETNDA01615152450d09-b77d-4bae-8d21-6394408e3f88

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200139ANDACorepharma, Llc2003-07-01METHENAMINE HIPPURATEORALTABLETANDA076411ad741dc5-816c-4ab2-9273-9b1a586149bc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290715ANDAGolden State Medical Supply, Inc.2003-07-01METHENAMINE HIPPURATEORALTABLET647200139ANDA076411f1843e43-2bb2-400a-b10b-c78397386338
2681510984ANDACarilion Materials Management2003-07-01METHENAMINE HIPPURATEORALTABLET647200139ANDA0764114d649196-b7b4-4d49-a905-80d07bc49f97

methenamine mandelate 1000 mg oral tablet

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1636294937UNAPPROVED DRUG OTHER MARKETING CATEGORYBryant Ranch Prepack2010-02-01METHENAMINE MANDELATEORALTABLET, FILM COATED1392501079dfb9936-1136-4c2f-a98f-1fae3fcf70d2

methenamine mandelate 500 mg oral tablet

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1427990105UNAPPROVED DRUG OTHER MARKETING CATEGORYEdenbridge Pharmaceuticals, Llc2009-12-15METHENAMINE MANDELATEORALTABLETcc299e8a-cf9a-4dc6-b6e6-972141e59296

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076411METHENAMINE HIPPURATECOREPHARMA LLC2003-06-20ANDA076411_001
2NDA016151UREXCOUNTY LINE PHARMACEUTICALS LLCNDA016151_001
3NDA017681HIPREXSANOFI AVENTIS US LLCNDA017681_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076411_001RXMETHENAMINE HIPPURATE (1GM)ORALTABLETFalseAB2003-06-20METHENAMINE HIPPURATE
2NDA016151_001RXMETHENAMINE HIPPURATE (1GM)ORALTABLETFalseABUREX
3NDA017681_001RXMETHENAMINE HIPPURATE (1GM)ORALTABLETTrueABHIPREX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14d649196-b7b4-4d49-a905-80d07bc49f97 (view SPL)METHENAMINE HIPPURATE TABLETS USP 1 g Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-03-242681510984
252450d09-b77d-4bae-8d21-6394408e3f88 (view SPL)Methenamine Hippurate Tablets 1 gPI -CLP020A02/10prescriptionHuman PrescriptionCounty Line Pharmaceuticals, LlcANALYSIS, MANUFACTURE2010-05-031431990020
37488ad5c-376d-47a2-8c23-47eff94547fb (view SPL)HIPREX (methenamine hippurate tablets USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-03-054000680277
49dfb9936-1136-4c2f-a98f-1fae3fcf70d2 (view SPL)Methenamine Mandelate Tablets (USP)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081000636294937
5ad741dc5-816c-4ab2-9273-9b1a586149bc (view SPL)METHENAMINE HIPPURATE TABLETS USP 1 g Rx onlyprescriptionHuman PrescriptionCorepharma, Llc2014-03-248647200139
6cc299e8a-cf9a-4dc6-b6e6-972141e59296 (view SPL)prescriptionHuman PrescriptionEdenbridge Pharmaceuticals, Llcmanufacture, pack2012-04-132427990105, 427990106
7d21a1fdb-7111-4038-975f-f93de44d63a7 (view SPL)Methenamine Mandelate Tablets (USP)prescriptionHuman PrescriptionSeton Pharmaceuticals2012-01-121139250107
8f1843e43-2bb2-400a-b10b-c78397386338 (view SPL)METHENAMINE HIPPURATE TABLETS USP 1 gmRx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290715
9fa188434-4c82-448e-9693-f220d1aee0a5 (view SPL)METHENAMINE HIPPURATE TABLETS, USPprescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2012-01-311009551037

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