moexipril Oral Tablet

Brand(s)
Univasc
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Schwarz Pharma (2012-07-31)
Oldest Current Product
1995-07-15
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\MOEXIPRIL
FDAOB
ORAL\TABLET\MOEXIPRIL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\MOEXIPRIL HYDROCHLORIDE
ORAL\TABLET\MOEXIPRIL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\MOEXIPRILAT
ORAL\TABLET\MOEXIPRILAT

product(s) by strength(s)

moexipril hydrochloride 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000913715UnivascNDASchwarz Pharma1995-07-15MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA020312e16c2ad3-1ce5-48fc-96b2-5d63dc6b68d5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935150ANDATeva Pharmaceuticals Usa Inc2003-05-08MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0762045d4078f3-b621-475f-a4e6-005de2e62b32
2605050272ANDAApotex Corp2008-06-09MOEXIPRIL HYDROCHLORIDEORALTABLETANDA078454d18108f5-98ca-1220-d145-bcf4e71ceaee
3684620208ANDAGlenmark Generics Inc., Usa2010-12-31MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA090416baac91ad-f8ee-4694-89f8-5c47a8eda39a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684883ANDAPhysicians Total Care, Inc.2004-04-27MOEXIPRIL HYDROCHLORIDEORALTABLET605050272ANDA07845456bf1b0a-463a-4324-957b-585d4cf352ee

moexipril hydrochloride 7.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000913707UnivascNDASchwarz Pharma1995-07-15MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDNDA020312e16c2ad3-1ce5-48fc-96b2-5d63dc6b68d5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930017ANDATeva Pharmaceuticals Usa Inc2003-05-08MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0762045d4078f3-b621-475f-a4e6-005de2e62b32
2605050271ANDAApotex Corp2008-06-09MOEXIPRIL HYDROCHLORIDEORALTABLETANDA078454d18108f5-98ca-1220-d145-bcf4e71ceaee
3684620209ANDAGlenmark Generics Inc., Usa2010-12-31MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATEDANDA090416baac91ad-f8ee-4694-89f8-5c47a8eda39a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685928ANDAPhysicians Total Care, Inc.2008-08-14MOEXIPRIL HYDROCHLORIDEORALTABLET605050271ANDA07845456bf1b0a-463a-4324-957b-585d4cf352ee
2681511472ANDACarilion Materials Management2003-05-08MOEXIPRIL HYDROCHLORIDEORALTABLET, FILM COATED000930017ANDA07620483a79dc8-3c0d-434f-b7ed-13af9f340994

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076204MOEXIPRIL HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2003-05-08ANDA076204_001, ANDA076204_002
2ANDA077536MOEXIPRIL HYDROCHLORIDEPADDOCK LABORATORIES LLC2006-11-30ANDA077536_001, ANDA077536_002
3ANDA078454MOEXIPRIL HYDROCHLORIDEAPOTEX INC2008-06-02ANDA078454_001, ANDA078454_002
4ANDA090416MOEXIPRIL HYDROCHLORIDEGLENMARK GENERICS LTD2010-03-30ANDA090416_001, ANDA090416_002
5NDA020312UNIVASCUCB INC1995-04-19NDA020312_001, NDA020312_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076204_001RXMOEXIPRIL HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2003-05-08MOEXIPRIL HYDROCHLORIDE
2ANDA076204_002RXMOEXIPRIL HYDROCHLORIDE (15MG)ORALTABLETFalseAB2003-05-08MOEXIPRIL HYDROCHLORIDE
3ANDA077536_001RXMOEXIPRIL HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2006-11-30MOEXIPRIL HYDROCHLORIDE
4ANDA077536_002RXMOEXIPRIL HYDROCHLORIDE (15MG)ORALTABLETFalseAB2006-11-30MOEXIPRIL HYDROCHLORIDE
5ANDA078454_001RXMOEXIPRIL HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2008-06-02MOEXIPRIL HYDROCHLORIDE
6ANDA078454_002RXMOEXIPRIL HYDROCHLORIDE (15MG)ORALTABLETFalseAB2008-06-02MOEXIPRIL HYDROCHLORIDE
7ANDA090416_001RXMOEXIPRIL HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2010-03-30MOEXIPRIL HYDROCHLORIDE
8ANDA090416_002RXMOEXIPRIL HYDROCHLORIDE (15MG)ORALTABLETFalseAB2010-03-30MOEXIPRIL HYDROCHLORIDE
9NDA020312_001RXMOEXIPRIL HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB1995-04-19UNIVASC
10NDA020312_002RXMOEXIPRIL HYDROCHLORIDE (15MG)ORALTABLETTrueAB1995-04-19UNIVASC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
156bf1b0a-463a-4324-957b-585d4cf352ee (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-04-141548684883, 548685928
25d4078f3-b621-475f-a4e6-005de2e62b32 (view SPL)MOEXIPRIL HYDROCHLORIDE TABLETS, 7.5 mg and 15 mg00175150Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-10-076000930017, 000935150
383a79dc8-3c0d-434f-b7ed-13af9f340994 (view SPL)MOEXIPRIL HYDROCHLORIDE TABLETS, 7.5 mg and 15 mg 0017 5150 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-10-072681511472
4baac91ad-f8ee-4694-89f8-5c47a8eda39a (view SPL)Moexipril Hydrochloride Tablets 7.5 mg and 15 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-11-197684620208, 684620209
5d18108f5-98ca-1220-d145-bcf4e71ceaee (view SPL)Moexipril Hydrochloride Tablets 7.5 mg and 15 mgprescriptionHuman PrescriptionApotex Corp2013-01-312605050271, 605050272
6e16c2ad3-1ce5-48fc-96b2-5d63dc6b68d5 (view SPL)univasc tablets (moexipril hydrochloride)prescriptionHuman PrescriptionSchwarz Pharma2012-07-318000913707, 000913715

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