Betaxolol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Epic Pharma, Llc (2015-04-13)
Oldest Current Product
2003-10-07
License(s)
ANDA
RxNORM
ORAL TABLET\BETAXOLOL
FDAOB
ORAL\TABLET\BETAXOLOL HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\BETAXOLOL HYDROCHLORIDE
ORAL\TABLET, FILM COATED\BETAXOLOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\BETAXOLOL
ORAL\TABLET, FILM COATED\BETAXOLOL

product(s) by strength(s)

betaxolol hydrochloride 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1107020013ANDAKvk-Tech, Inc.2011-11-02BETAXOLOL HYDROCHLORIDEORALTABLET, COATEDANDA078962f3b50bbb-df03-4ed7-9d8d-180edc2abd54
2428060038ANDAEpic Pharma, Llc2010-07-20BETAXOLOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA075541bf716efe-0a9f-43b1-9d8a-c69330b82e18

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684932ANDAPhysicians Total Care, Inc.2003-10-07BETAXOLOL HYDROCHLORIDEORALTABLET, FILM COATED428060038ANDA07554194fa6c50-de10-4c07-a668-1880061561cc
2604290753ANDAGolden State Medical Supply, Inc.2008-06-27BETAXOLOL HYDROCHLORIDEORALTABLET, FILM COATED107020013ANDA0789629a58c45d-4b14-44d7-86ed-2997ac6942dd

betaxolol hydrochloride 20 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428060039ANDAEpic Pharma, Llc2010-07-20BETAXOLOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA075541bf716efe-0a9f-43b1-9d8a-c69330b82e18

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290754ANDAGolden State Medical Supply, Inc.2008-06-27BETAXOLOL HYDROCHLORIDEORALTABLET, FILM COATED107020014ANDA0789629a58c45d-4b14-44d7-86ed-2997ac6942dd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075541BETAXOLOL HYDROCHLORIDEEPIC PHARMA LLC1999-10-22ANDA075541_001, ANDA075541_002
2ANDA078962BETAXOLOL HYDROCHLORIDEKVK TECH INC2008-06-27ANDA078962_001, ANDA078962_002
3NDA019507KERLONETrueSANOFI AVENTIS US LLC1989-10-27NDA019507_001, NDA019507_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075541_001RXBETAXOLOL HYDROCHLORIDE (10MG)ORALTABLETFalseAB1999-10-22BETAXOLOL HYDROCHLORIDE
2ANDA075541_002RXBETAXOLOL HYDROCHLORIDE (20MG)ORALTABLETTrueAB1999-10-22BETAXOLOL HYDROCHLORIDE
3ANDA078962_001RXBETAXOLOL HYDROCHLORIDE (10MG)ORALTABLETFalseAB2008-06-27BETAXOLOL HYDROCHLORIDE
4ANDA078962_002RXBETAXOLOL HYDROCHLORIDE (20MG)ORALTABLETFalseAB2008-06-27BETAXOLOL HYDROCHLORIDE
5NDA019507_001discontinuedBETAXOLOL HYDROCHLORIDE (10MG)ORALTABLETFalse1989-10-27KERLONE
6NDA019507_002discontinuedBETAXOLOL HYDROCHLORIDE (20MG)ORALTABLETFalse1989-10-27KERLONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
194fa6c50-de10-4c07-a668-1880061561cc (view SPL)Betaxolol Tablets USP, Film-Coated Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-152548684932
29a58c45d-4b14-44d7-86ed-2997ac6942dd (view SPL)Betaxolol Tablets, USP Rx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290753, 604290754
3bf716efe-0a9f-43b1-9d8a-c69330b82e18 (view SPL)Betaxolol Tablets USP, Film-Coated Rx onlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-04-137428060038, 428060039
4f3b50bbb-df03-4ed7-9d8d-180edc2abd54 (view SPL)Betaxolol Tablets, USPprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2015-08-144107020013

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