Triazolam Oral Tablet

Brand(s)
Halcion
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-08-25)
Oldest Current Product
1982-11-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TRIAZOLAM
FDAOB
ORAL\TABLET\TRIAZOLAM
SPL Active
ORAL\TABLET\TRIAZOLAM
SPL Moiety
ORAL\TABLET\TRIAZOLAM

product(s) by strength(s)

triazolam 0.125 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000544858ANDARoxane Laboratories, Inc2009-07-132017-01-07TRIAZOLAMORALTABLETANDA074224db564864-17fc-4ba5-a438-a467ef57a0ca
2000548858ANDARoxane Laboratories, Inc1994-06-012017-01-07TRIAZOLAMORALTABLETANDA074224db564864-17fc-4ba5-a438-a467ef57a0ca
3597623717NDA AUTHORIZED GENERICGreenstone Llc1982-11-15TRIAZOLAMORALTABLETNDA0178925add318e-11b9-42f8-b052-0d8cebb32fcf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950303ANDARebel Distributors Corp2009-07-13TRIAZOLAMORALTABLET000544858ANDA07422473db8a0e-02a9-4613-8feb-e847c965d34f

triazolam 0.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090017HalcionNDAPharmacia And Upjohn Company1982-11-15TRIAZOLAMORALTABLETNDA017892a0da0dba-a56d-486b-a45b-e8a7cdfbeac6

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000544859ANDARoxane Laboratories, Inc1994-06-012014-01-15TRIAZOLAMORALTABLETANDA074224db564864-17fc-4ba5-a438-a467ef57a0ca
2000548859ANDARoxane Laboratories, Inc1994-06-012016-01-30TRIAZOLAMORALTABLETANDA074224db564864-17fc-4ba5-a438-a467ef57a0ca
3597623718NDA AUTHORIZED GENERICGreenstone Llc1982-11-15TRIAZOLAMORALTABLETNDA0178925add318e-11b9-42f8-b052-0d8cebb32fcf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900236NDA AUTHORIZED GENERICStat Rx Usa Llc1982-11-15TRIAZOLAMORALTABLET597623718NDA017892db1311ad-9732-4fdb-80dc-95b09077e3d0
2216950284ANDARebel Distributors Corp1994-06-01TRIAZOLAMORALTABLET000544859ANDA07422473db8a0e-02a9-4613-8feb-e847c965d34f
3499990055ANDALake Erie Medical Dba Quality Care Products Llc2011-06-01TRIAZOLAMORALTABLET000544859ANDA074224aef73b7b-c72b-4775-abd6-8f0144cfb14d
4500900522NDA AUTHORIZED GENERICA-S Medication Solutions Llc1982-11-15TRIAZOLAMORALTABLET597623718NDA0178927c67cf7d-2185-45d1-901b-e67d138d07a9
5504369036ANDAUnit Dose Services1994-06-01TRIAZOLAMORALTABLET000544859ANDA0742249bf087eb-daeb-41f7-80b5-5fc70927011d
6545693966NDA AUTHORIZED GENERICA-S Medication Solutions Llc1982-11-15TRIAZOLAMORALTABLET597623718NDA017892919f356f-edec-4fd2-8f4a-26f45dd20516
7545696376ANDAA-S Medication Solutions Llc1994-06-01TRIAZOLAMORALTABLET000548859ANDA0742242840e9b7-d692-413f-9d66-2589f7589971
8552890787NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.1982-11-15TRIAZOLAMORALTABLET597623718NDA017892b130a3b2-e34a-411f-b3d8-121ae81c98e0
9636292956ANDABryant Ranch Prepack1994-06-01TRIAZOLAMORALTABLET000544859ANDA07422412c0c495-a032-382e-9b04-37018090cad0
10675440725ANDAAphena Pharma Solutions - Tennessee, Inc.1994-06-01TRIAZOLAMORALTABLET000544859ANDA0742243aa63f5c-2490-4bce-bc5e-35331d5d51ad
11687889542ANDAPreferred Pharmaceuticals, Inc.2013-11-05TRIAZOLAMORALTABLET000544859ANDA074224611724e3-af8a-4e1c-9d45-6855905c2f92

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074031TRIAZOLAMMYLAN PHARMACEUTICALS INC1994-03-25ANDA074031_001, ANDA074031_002
2ANDA074224TRIAZOLAMROXANE LABORATORIES INC1994-06-01ANDA074224_001, ANDA074224_002
3ANDA074445TRIAZOLAMTrueWATSON LABORATORIES INC1995-10-20ANDA074445_001, ANDA074445_002
4NDA017892HALCIONPHARMACIA AND UPJOHN CO1982-11-15NDA017892_001, NDA017892_002, NDA017892_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074031_001RXTRIAZOLAM (0.125MG)ORALTABLETFalseAB1994-03-25TRIAZOLAM
2ANDA074031_002RXTRIAZOLAM (0.25MG)ORALTABLETFalseAB1994-03-25TRIAZOLAM
3ANDA074224_001RXTRIAZOLAM (0.125MG)ORALTABLETFalseAB1994-06-01TRIAZOLAM
4ANDA074224_002RXTRIAZOLAM (0.25MG)ORALTABLETFalseAB1994-06-01TRIAZOLAM
5ANDA074445_001discontinuedTRIAZOLAM (0.125MG)ORALTABLETFalse1995-10-20TRIAZOLAM
6ANDA074445_002discontinuedTRIAZOLAM (0.25MG)ORALTABLETFalse1995-10-20TRIAZOLAM
7NDA017892_001RXTRIAZOLAM (0.25MG)ORALTABLETTrueAB1982-11-15HALCION
8NDA017892_002discontinuedTRIAZOLAM (0.5MG)ORALTABLETFalse1982-11-15HALCION
9NDA017892_003RXTRIAZOLAM (0.125MG)ORALTABLETFalseAB1985-04-26HALCION

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112c0c495-a032-382e-9b04-37018090cad0 (view SPL)TRIAZOLAM Tablets, USP 0.125 mg and 0.25 mg CIVprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-283636292956
22840e9b7-d692-413f-9d66-2589f7589971 (view SPL)TRIAZOLAM Tablets, USP CIV 0.125 mg and 0.25 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-05-021545696376
33aa63f5c-2490-4bce-bc5e-35331d5d51ad (view SPL)TRIAZOLAM Tablets, USP 0.25 mg CIVprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2012-06-201675440725
45add318e-11b9-42f8-b052-0d8cebb32fcf (view SPL)Triazolam tablets, USP CIVprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-10-0810597623717, 597623718
5611724e3-af8a-4e1c-9d45-6855905c2f92 (view SPL)TRIAZOLAM Tablets, USP CIV 0.125 mg and 0.25 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.STERILIZE2013-11-191687889542
673db8a0e-02a9-4613-8feb-e847c965d34f (view SPL)TRIAZOLAM Tablets, USP 0.125 mg and 0.25 mg CIVprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-012216950284, 216950303
77c67cf7d-2185-45d1-901b-e67d138d07a9 (view SPL)Triazolam tablets, USP CIVprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-01-261500900522
8919f356f-edec-4fd2-8f4a-26f45dd20516 (view SPL)Triazolam tablets, USP CIVprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-061545693966
99bf087eb-daeb-41f7-80b5-5fc70927011d (view SPL)TRIAZOLAM Tablets, USP 0.125 mg and 0.25 mg CIVprescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-10-183504369036
10a0da0dba-a56d-486b-a45b-e8a7cdfbeac6 (view SPL)Halcion triazolam tablets, USP CIVprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-2513000090017
11aef73b7b-c72b-4775-abd6-8f0144cfb14d (view SPL)TRIAZOLAM Tablets, USP 0.125 mg and 0.25 mg CIVprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-12-283426499990055
12b130a3b2-e34a-411f-b3d8-121ae81c98e0 (view SPL)Triazolam tablets, USP CIVprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-063552890787
13db1311ad-9732-4fdb-80dc-95b09077e3d0 (view SPL)Triazolam tablets, USP CIVprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-031165900236
14db564864-17fc-4ba5-a438-a467ef57a0ca (view SPL)TRIAZOLAM Tablets, USP CIV 0.125 mg and 0.25 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-01-0713000544858, 000544859, 000548858, 000548859

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