Acetazolamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2015-10-09)
Oldest Current Product
1978-03-31
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAZOLAMIDE
FDAOB
ORAL\TABLET\ACETAZOLAMIDE
SPL Active
ORAL\TABLET\ACETAZOLAMIDE
SPL Moiety
ORAL\TABLET\ACETAZOLAMIDE

product(s) by strength(s)

acetazolamide 125 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724022ANDATaro Pharmaceuticals U.S.A., Inc.1997-05-28ACETAZOLAMIDEORALTABLETANDA040195abeb13eb-66a5-4030-9bc2-5981acd196b9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545694387ANDAA-S Medication Solutions Llc1997-05-28ACETAZOLAMIDEORALTABLET516724022ANDA0401953e1d2008-3649-485f-ba30-4b966e360585
2552890720ANDAPd-Rx Pharmaceuticals, Inc.1997-05-28ACETAZOLAMIDEORALTABLET516724022ANDA040195bd911de5-ea56-41ba-a328-20c8bfe7fe3b
3604290033ANDAGolden State Medical Supply, Inc.1997-05-28ACETAZOLAMIDEORALTABLET516724022ANDA040195ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c

acetazolamide 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271050ANDALannett Company, Inc.1978-03-31ACETAZOLAMIDEORALTABLETANDA084840c1c76f21-e1fc-40ea-947a-bc9c752f80c8
2101350567ANDAMarlex Pharmaceuticals Inc2014-10-01ACETAZOLAMIDEORALTABLETANDA0848408cd20635-91d0-4565-bc2c-778806178ac8
3516724023ANDATaro Pharmaceuticals U.S.A., Inc.1997-05-28ACETAZOLAMIDEORALTABLETANDA040195abeb13eb-66a5-4030-9bc2-5981acd196b9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151511ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1997-05-28ACETAZOLAMIDEORALTABLET516724023ANDA0401958101a7a6-d5cf-43ab-8f55-7909eba27add
2422910103ANDAAvkare, Inc.2012-07-02ACETAZOLAMIDEORALTABLET005271050ANDA0848401cb912d1-0d48-7e6f-a7b6-f766be6b86b0
3521250095ANDARemedyrepack Inc.2013-03-11ACETAZOLAMIDEORALTABLET005271050ANDA084840b8ea24ea-450f-4459-a40f-78a9a4dfe581
4521250182ANDARemedyrepack Inc.2013-03-27ACETAZOLAMIDEORALTABLET516724023ANDA0401952bda071e-0f9c-4a13-be9f-513145e32723
5545691697ANDAA-S Medication Solutions Llc1997-05-28ACETAZOLAMIDEORALTABLET516724023ANDA040195ef46f395-997f-4d55-8461-b418bd3a53bb
6548681195ANDAPhysicians Total Care, Inc.2010-02-09ACETAZOLAMIDEORALTABLET005271050ANDA08484059050278-167e-4641-a253-4e57653f8b6b
7551543025ANDACardinal Health1997-05-28ACETAZOLAMIDEORALTABLET516724023ANDA04019514271670-a13b-4f7d-a27b-a92a27199cc6, bc614baa-8649-4fea-a482-ee121fd3dcd6
8552890221ANDAPd-Rx Pharmaceuticals, Inc.1997-05-28ACETAZOLAMIDEORALTABLET516724023ANDA040195aa0796a0-2687-4cd6-b0d9-a5bf957c0d07
9604290034ANDAGolden State Medical Supply, Inc.1997-05-28ACETAZOLAMIDEORALTABLET516724023ANDA040195ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c
10672960801ANDARedpharm Drug Inc.1978-03-31ACETAZOLAMIDEORALTABLET005271050ANDA0848406972d9c1-36ec-4246-bf7b-13206d5952c3
11680840541ANDAAmerican Health Packaging2011-11-01ACETAZOLAMIDEORALTABLET005271050ANDA0848407bcb16ee-2233-462c-bf6f-4d55eecbed29

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040195ACETAZOLAMIDETARO PHARMACEUTICAL INDUSTRIES LTD1997-05-28ANDA040195_001, ANDA040195_002
2ANDA083320ACETAZOLAMIDETrueALRA LABORATORIES INCANDA083320_001
3ANDA084498ACETAZOLAMIDETrueWATSON LABORATORIES INCANDA084498_002
4ANDA084840ACETAZOLAMIDELANNETT CO INCANDA084840_001
5ANDA087654ACETAZOLAMIDETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1982-02-05ANDA087654_001
6ANDA087686ACETAZOLAMIDETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1982-10-20ANDA087686_001
7ANDA088882ACETAZOLAMIDETrueWATSON LABORATORIES INC1985-10-22ANDA088882_001
8ANDA089752ACETAZOLAMIDEMUTUAL PHARMACEUTICAL CO INC1988-06-22ANDA089752_001
9ANDA089753ACETAZOLAMIDETrueMUTUAL PHARMACEUTICAL CO INC1988-06-22ANDA089753_001
10NDA008943DIAMOXTrueTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INCNDA008943_001, NDA008943_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040195_001RXACETAZOLAMIDE (125MG)ORALTABLETFalseAB1997-05-28ACETAZOLAMIDE
2ANDA040195_002RXACETAZOLAMIDE (250MG)ORALTABLETTrueAB1997-05-28ACETAZOLAMIDE
3ANDA083320_001discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalseACETAZOLAMIDE
4ANDA084498_002discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalseACETAZOLAMIDE
5ANDA084840_001RXACETAZOLAMIDE (250MG)ORALTABLETFalseABACETAZOLAMIDE
6ANDA087654_001discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalse1982-02-05ACETAZOLAMIDE
7ANDA087686_001discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalse1982-10-20ACETAZOLAMIDE
8ANDA088882_001discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalse1985-10-22ACETAZOLAMIDE
9ANDA089752_001RXACETAZOLAMIDE (125MG)ORALTABLETFalseAB1988-06-22ACETAZOLAMIDE
10ANDA089753_001discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalse1988-06-22ACETAZOLAMIDE
11NDA008943_001discontinuedACETAZOLAMIDE (125MG)ORALTABLETFalseDIAMOX
12NDA008943_002discontinuedACETAZOLAMIDE (250MG)ORALTABLETFalseDIAMOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
114271670-a13b-4f7d-a27b-a92a27199cc6 (view SPL)AcetaZOLAMIDE Tablet USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-03-311551543025
21cb912d1-0d48-7e6f-a7b6-f766be6b86b0 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionAvkare, Inc.2015-10-223422910103
32bda071e-0f9c-4a13-be9f-513145e32723 (view SPL)Acetazolamide Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-271521250182
43e1d2008-3649-485f-ba30-4b966e360585 (view SPL)Acetazolamide Tablets USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545694387
559050278-167e-4641-a253-4e57653f8b6b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-182548681195
66972d9c1-36ec-4246-bf7b-13206d5952c3 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionRedpharm Drug Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-08-051672960801
77bcb16ee-2233-462c-bf6f-4d55eecbed29 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-132680840541
88101a7a6-d5cf-43ab-8f55-7909eba27add (view SPL)AcetaZOLAMIDE Tablet USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2011-10-261006151511
98cd20635-91d0-4565-bc2c-778806178ac8 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-03-131101350567
10aa0796a0-2687-4cd6-b0d9-a5bf957c0d07 (view SPL)Acetazolamide Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-082552890221
11abeb13eb-66a5-4030-9bc2-5981acd196b9 (view SPL)AcetaZOLAMIDE Tablets USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-10-094516724022, 516724023
12b8ea24ea-450f-4459-a40f-78a9a4dfe581 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-111521250095
13bc614baa-8649-4fea-a482-ee121fd3dcd6 (view SPL)AcetaZOLAMIDE Tablet USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-041551543025
14bd911de5-ea56-41ba-a328-20c8bfe7fe3b (view SPL)Acetazolamide Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-082552890720
15c1c76f21-e1fc-40ea-947a-bc9c752f80c8 (view SPL)AcetaZOLAMIDE TABLETS USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-024005271050
16ceb5cac3-bbfb-42fa-8b29-c0ef5ed0913c (view SPL)AcetaZOLAMIDE Tablet USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-012604290033, 604290034
17ef46f395-997f-4d55-8461-b418bd3a53bb (view SPL)Acetazolamide Tablets USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545691697

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