Clarithromycin Extended Release Oral Tablet

Brand(s)
Biaxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-02-11)
Oldest Current Product
2000-03-03
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\CLARITHROMYCIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\CLARITHROMYCIN
SPL Active
ORAL\TABLET, EXTENDED RELEASE\CLARITHROMYCIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CLARITHROMYCIN
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\CLARITHROMYCIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CLARITHROMYCIN

product(s) by strength(s)

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630565ANDAPd-Rx Pharmaceuticals, Inc.2008-01-01CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASE005912805ANDA0651456883d758-f83b-48b5-9ec2-d096cf9aa95f

24 hr clarithromycin 500 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937244ANDATeva Pharmaceuticals Usa Inc2006-06-23CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASEANDA065154a58fc044-95b2-4443-93b0-2ca7a6f6c159
2005912805ANDAWatson Laboratories, Inc.2008-01-01CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASEANDA065145d5be5f12-6392-4d7d-ab23-ebc205ac1a85

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1000743165BiaxinNDAAbbvie Inc.2000-03-03CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASENDA050775aa44552c-3cfe-4111-8aa5-4251aeed9be9
2545694953BiaxinNDAA-S Medication Solutions Llc2000-03-03CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASE000743165NDA0507758216a1e6-0d91-48e8-9b61-7215c0157032
3548684191BiaxinNDAPhysicians Total Care, Inc.2000-11-03CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASE000743165NDA0507752e899f4a-a2e9-445c-a0ed-6ad811e997e6
4683820763NDAZydus Pharmaceuticals (Usa) Inc.2000-03-032014-10-31CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASENDA05077590d35dd6-a918-c4ab-bc7e-43652ce9b3b4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630520ANDAPd-Rx Pharmaceuticals, Inc.2008-01-01CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASE005912805ANDA06514564fb3925-ad18-436a-a059-4fce3d7c4316
2636291284ANDABryant Ranch Prepack2009-05-30CLARITHROMYCINORALTABLET, EXTENDED RELEASE000937244ANDA0651545ce42a9d-cdce-4889-9def-cb7be2cb8d7b
3663360429ANDADispensing Solutions, Inc.2008-01-01CLARITHROMYCINORALTABLET, FILM COATED, EXTENDED RELEASE620370777ANDA065145d9db2fd3-a668-4d37-9082-18f6ceb8c3cb

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA065145CLARITHROMYCINACTAVIS LABORATORIES FL INC2004-06-24ANDA065145_001
2ANDA065154CLARITHROMYCINTEVA PHARMACEUTICALS USA INC2005-05-18ANDA065154_001
3ANDA065210CLARITHROMYCINTrueRANBAXY LABORATORIES LTD2005-01-26ANDA065210_001
4ANDA065250CLARITHROMYCINTrueSANDOZ2005-08-25ANDA065250_001
5ANDA202532CLARITHROMYCINLUPIN LTD2015-09-15ANDA202532_001
6NDA050775BIAXIN XLTrueABBVIE INC2000-03-03p6010718, TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS, SUBSTANCE
p6551616, TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
NDA050775_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065145_001RXCLARITHROMYCIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-06-24CLARITHROMYCIN
2ANDA065154_001RXCLARITHROMYCIN (500MG)ORALTABLET, EXTENDED RELEASETrueAB2005-05-18CLARITHROMYCIN
3ANDA065210_001discontinuedCLARITHROMYCIN (1GM)ORALTABLET, EXTENDED RELEASEFalse2005-01-26CLARITHROMYCIN
4ANDA065250_001discontinuedCLARITHROMYCIN (500MG)ORALTABLET, EXTENDED RELEASEFalse2005-08-25CLARITHROMYCIN
5ANDA202532_001RXCLARITHROMYCIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-09-15CLARITHROMYCIN
6NDA050775_001discontinuedCLARITHROMYCIN (500MG)ORALTABLET, EXTENDED RELEASEFalse2000-03-03BIAXIN XL

patent(s)

#idexpiration dateapplication(s)
1p6010718 (view patent)2017-04-11NDA050775
2p6551616 (view patent)2017-06-15NDA050775

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12e899f4a-a2e9-445c-a0ed-6ad811e997e6 (view SPL)BIAXIN Filmtab(clarithromycin tablets, USP)BIAXIN XL Filmtab(clarithromycin extended-release tablets)BIAXIN Granules(clarithromycin for oral suspension, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-221548684191, 548682338, 548683384, 548683820, 548684919Clarithromycin Oral Tablet
Clarithromycin Oral Suspension
25ce42a9d-cdce-4889-9def-cb7be2cb8d7b (view SPL)Clarithromycin ER 500mg TabletprescriptionHuman PrescriptionBryant Ranch Prepackrepack2012-10-121003636291284
364fb3925-ad18-436a-a059-4fce3d7c4316 (view SPL)CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-11-1122430630520
46883d758-f83b-48b5-9ec2-d096cf9aa95f (view SPL)CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-11-1122430630565
58216a1e6-0d91-48e8-9b61-7215c0157032 (view SPL)BIAXIN Filmtab(clarithromycin tablets, USP)BIAXIN XL Filmtab(clarithromycin extended-release tablets)BIAXIN Granules(clarithromycin for oral suspension, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel, repack2013-10-261545694953, 545693439Clarithromycin Oral Tablet
690d35dd6-a918-c4ab-bc7e-43652ce9b3b4 (view SPL)CLARITHROMYCIN TABLETS, USPCLARITHROMYCIN FOR ORAL SUSPENSION, USPCLARITHROMYCIN EXTENDED-RELEASE TABLETSprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.2015-10-2365683820763, 683820761, 683820762, 683820764, 683820765Clarithromycin Oral Tablet
Clarithromycin Oral Suspension
7a58fc044-95b2-4443-93b0-2ca7a6f6c159 (view SPL)CLARITHROMYCIN EXTENDED-RELEASE TABLETS USP7244Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-02-118000937244
8aa44552c-3cfe-4111-8aa5-4251aeed9be9 (view SPL)BIAXIN Filmtab(clarithromycin tablets, USP)BIAXIN XL Filmtab(clarithromycin extended-release tablets)BIAXIN Granules(clarithromycin for oral suspension, USP)prescriptionHuman PrescriptionAbbvie Inc.2015-10-271531000743165, 000742586, 000743163, 000743188, 000743368Clarithromycin Oral Tablet
Clarithromycin Oral Suspension
9d5be5f12-6392-4d7d-ab23-ebc205ac1a85 (view SPL)CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-0127005912805
10d9db2fd3-a668-4d37-9082-18f6ceb8c3cb (view SPL)CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-021663360429

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