Triamterene Oral Capsule

Brand(s)
Dyrenium
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Concordia Pharmaceuticals Inc. (2015-07-17)
Oldest Current Product
1999-01-01
License(s)
NDA
RxNORM
ORAL CAPSULE\TRIAMTERENE
FDAOB
ORAL\CAPSULE\TRIAMTERENE
SPL Active
ORAL\CAPSULE\TRIAMTERENE
SPL Moiety
ORAL\CAPSULE\TRIAMTERENE

product(s) by strength(s)

triamterene 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1651970003DyreniumNDAWellspring Pharmaceutical Corporation1999-01-012020-01-31TRIAMTERENEORALCAPSULENDA0131745012f997-9fb2-4c3d-99fd-4f7efd7c39af

triamterene 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1592120002DyreniumNDAConcordia Pharmaceuticals Inc.1999-10-01TRIAMTERENEORALCAPSULENDA013174ebb177c0-d45d-4443-a85a-e76bd9931a42

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681511494DyreniumNDACarilion Materials Management1999-10-01TRIAMTERENEORALCAPSULE651970002NDA013174ffe24e3d-cfe8-4d5a-8213-69f0bbc9f4d5

application(s)

#idtitleapplicantapproved drug
1NDA013174DYRENIUMCONCORDIA PHARMACEUTICALS INCNDA013174_001, NDA013174_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1NDA013174_001RXTRIAMTERENE (50MG)ORALCAPSULEFalseDYRENIUM
2NDA013174_002RXTRIAMTERENE (100MG)ORALCAPSULETrueDYRENIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15012f997-9fb2-4c3d-99fd-4f7efd7c39af (view SPL)DYRENIUM (triamterene USP) Capsules 50 mg and 100 mgpotassium-sparing diureticprescriptionHuman PrescriptionWellspring Pharmaceutical Corporation2013-05-148651970003, 651970002
2ebb177c0-d45d-4443-a85a-e76bd9931a42 (view SPL)DYRENIUM (triamterene USP) Capsules 50 mg and 100 mgpotassium-sparing diureticprescriptionHuman PrescriptionConcordia Pharmaceuticals Inc.2015-07-171592120002, 592120003
3ffe24e3d-cfe8-4d5a-8213-69f0bbc9f4d5 (view SPL)DYRENIUM (triamterene USP) Capsules 50 mg and 100 mgpotassium-sparing diuretic prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-10-082681511494

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