Amiloride Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2012-02-15)
Oldest Current Product
1986-01-22
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\AMILORIDE
FDAOB
ORAL\TABLET\AMILORIDE HYDROCHLORIDE
SPL Active
ORAL\TABLET\AMILORIDE HYDROCHLORIDE
ORAL\TABLET\AMILORIDE HYDROCHLORIDE ANHYDROUS
SPL Moiety
ORAL\TABLET\AMILORIDE

product(s) by strength(s)

amiloride hydrochloride 5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740292NDAPaddock Laboratories, Llc2009-04-06AMILORIDE HYDROCHLORIDEORALTABLETNDA0182002b70cf0c-45be-428f-b396-5001ed4e30fc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422910122ANDAAvkare, Inc.2012-03-28AMILORIDE HYDROCHLORIDEORALTABLETANDA079133135f9cb8-17b6-e99a-57c3-2d992eddb8ef
2498840117ANDAPar Pharmaceutical Companies, Inc.1986-01-22AMILORIDE HYDROCHLORIDE ANHYDROUSORALTABLETANDA070346e0cc2d44-436a-47e8-a890-589882fff4c4
3649800151ANDARising Pharmaceuticals, Inc.2009-05-01AMILORIDE HYDROCHLORIDEORALTABLETANDA07913316fdc381-0a5b-419e-afaa-9cb2e61bd32e
4658410820ANDACadila Healthcare Limited2015-09-14AMILORIDE HYDROCHLORIDEORALTABLETANDA2041801b12b850-cf72-42bc-9fee-ba483e0c5756
5683820671ANDAZydus Pharmaceuticals (Usa) Inc.2015-09-14AMILORIDE HYDROCHLORIDEORALTABLETANDA20418089107b20-5437-45b6-958d-9880202edd87

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680071ANDAAvpak2013-01-28AMILORIDE HYDROCHLORIDEORALTABLET649800151ANDA0791330d1c0095-8dde-ab90-757b-d031b232e622
2548685214NDAPhysicians Total Care, Inc.2005-01-28AMILORIDE HYDROCHLORIDEORALTABLET005740292NDA0182001cf090a2-b6c0-42cd-857e-60a9cd85fe19
3681510162ANDACarilion Materials Management1986-01-22AMILORIDE HYDROCHLORIDE ANHYDROUSORALTABLET498840117ANDA070346875f3f5a-ed45-4646-8537-21f054302d6f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA070346AMILORIDE HYDROCHLORIDEPAR PHARMACEUTICAL INC1986-01-22ANDA070346_001
2ANDA079133AMILORIDE HYDROCHLORIDESIGMAPHARM LABORATORIES LLC2009-01-30ANDA079133_001
3ANDA204180AMILORIDE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2015-08-07ANDA204180_001
4NDA018200MIDAMORPADDOCK LABORATORIES LLCNDA018200_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070346_001RXAMILORIDE HYDROCHLORIDE (5MG)ORALTABLETTrueAB1986-01-22AMILORIDE HYDROCHLORIDE
2ANDA079133_001RXAMILORIDE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-01-30AMILORIDE HYDROCHLORIDE
3ANDA204180_001RXAMILORIDE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2015-08-07AMILORIDE HYDROCHLORIDE
4NDA018200_001RXAMILORIDE HYDROCHLORIDE (5MG)ORALTABLETFalseABMIDAMOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10d1c0095-8dde-ab90-757b-d031b232e622 (view SPL)AMILORIDE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionAvpak2014-09-102502680071
2135f9cb8-17b6-e99a-57c3-2d992eddb8ef (view SPL)AMILORIDE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionAvkare, Inc.2015-09-153422910122
316fdc381-0a5b-419e-afaa-9cb2e61bd32e (view SPL)AMILORIDE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.analysis, api manufacture, manufacture2010-12-124649800151
41b12b850-cf72-42bc-9fee-ba483e0c5756 (view SPL)Amiloride Hydrochloride Tablets, USP Rx onlyprescriptionHuman PrescriptionCadila Healthcare Limitedanalysis, manufacture2015-08-201658410820
51cf090a2-b6c0-42cd-857e-60a9cd85fe19 (view SPL)Amiloride HCl Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-06-301548685214
62b70cf0c-45be-428f-b396-5001ed4e30fc (view SPL)Amiloride HCl Tablets, USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2013-11-062005740292
7875f3f5a-ed45-4646-8537-21f054302d6f (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-02-152681510162
889107b20-5437-45b6-958d-9880202edd87 (view SPL)Amiloride Hydrochloride Tablets, USP Rx onlyprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, manufacture2015-08-201683820671
9e0cc2d44-436a-47e8-a890-589882fff4c4 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2012-02-155498840117

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