Probenecid Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2006-03-09)
Oldest Current Product
1976-01-13
License(s)
ANDA
RxNORM
ORAL TABLET\PROBENECID
FDAOB
ORAL\TABLET\PROBENECID
SPL Active
ORAL\TABLET, FILM COATED\PROBENECID
SPL Moiety
ORAL\TABLET, FILM COATED\PROBENECID

product(s) by strength(s)

probenecid 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780156ANDAMylan Pharmaceuticals Inc.1976-01-13PROBENECIDORALTABLET, FILM COATEDANDA08421111e8d542-e79f-4665-8b35-8aa194c55f33
2005271367ANDALannett Company, Inc.1976-07-29PROBENECIDORALTABLET, FILM COATEDANDA080966ab497fd8-00c3-4364-b003-b39d21fbdf38
3005915347ANDAWatson Laboratories, Inc.1983-07-01PROBENECIDORALTABLET, FILM COATEDANDA084442ae126418-5474-4fbe-b83c-bde8b2b4ae6e
4101350541ANDAMarlex Pharmaceuticals Inc1976-07-29PROBENECIDORALTABLET, FILM COATEDANDA0809665d552de5-2d18-4464-bcaf-0311fa3f080d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1118190282ANDAHhs/Program Support Center/Supply Service Center1983-07-01PROBENECIDORALTABLET, FILM COATED005915347ANDA0844425ca3dd4c-b8b4-4131-a066-214dabb2576f
2433530839ANDAAphena Pharma Solutions - Tennessee, Llc1976-07-29PROBENECIDORALTABLET, FILM COATED101350541ANDA08096614637e17-4265-4195-8182-7ca13796c684
3548680159ANDAPhysicians Total Care, Inc.1995-03-28PROBENECIDORALTABLET, FILM COATED005915347ANDA0844429eeedc83-f6cc-4383-83ec-d7992a96b7b4
4680840945ANDAAmerican Health Packaging2015-03-31PROBENECIDORALTABLET, FILM COATED005271367ANDA0809661bf9c422-a2a9-4155-b1e2-c545c280e688
5681511993ANDACarilion Materials Management1976-01-13PROBENECIDORALTABLET, FILM COATED003780156ANDA0842118459857e-1a52-45de-81e6-e06ce18508bb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080966PROBALANLANNETT CO INCANDA080966_001
2ANDA083740PROBENECIDTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1984-05-09ANDA083740_001
3ANDA084211PROBENECIDMYLAN PHARMACEUTICALS INCANDA084211_002
4ANDA084442PROBENECIDWATSON LABORATORIES INC1983-03-29ANDA084442_004
5ANDA086150PROBENECIDTrueWATSON LABORATORIES INC1982-04-23ANDA086150_002
6ANDA086917PROBENECIDTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086917_001
7NDA007898BENEMIDTrueMERCK AND CO INCNDA007898_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA080966_001RXPROBENECID (500MG)ORALTABLETFalseABPROBALAN
2ANDA083740_001discontinuedPROBENECID (500MG)ORALTABLETFalse1984-05-09PROBENECID
3ANDA084211_002RXPROBENECID (500MG)ORALTABLETTrueABPROBENECID
4ANDA084442_004RXPROBENECID (500MG)ORALTABLETFalseAB1983-03-29PROBENECID
5ANDA086150_002discontinuedPROBENECID (500MG)ORALTABLETFalse1982-04-23PROBENECID
6ANDA086917_001discontinuedPROBENECID (500MG)ORALTABLETFalsePROBENECID
7NDA007898_004discontinuedPROBENECID (500MG)ORALTABLETFalseBENEMID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
111e8d542-e79f-4665-8b35-8aa194c55f33 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2006-03-096003780156
214637e17-4265-4195-8182-7ca13796c684 (view SPL)Probenecid Tablets, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-281433530839
31bf9c422-a2a9-4155-b1e2-c545c280e688 (view SPL)PROBENECID TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-192680840945
45ca3dd4c-b8b4-4131-a066-214dabb2576f (view SPL)Probenecid Tablets USP Revised: June 2009Rx only 190811prescriptionHuman PrescriptionHhs/Program Support Center/Supply Service CenterRELABEL, REPACK2012-02-291118190282
55d552de5-2d18-4464-bcaf-0311fa3f080d (view SPL)Probenecid Tablets, USPprescriptionHuman PrescriptionMarlex Pharmaceuticals IncANALYSIS, LABEL, MANUFACTURE, PACK2013-05-162101350541
68459857e-1a52-45de-81e6-e06ce18508bb (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2006-03-092681511993
79eeedc83-f6cc-4383-83ec-d7992a96b7b4 (view SPL)Probenecid Tablets USP Revised: June 2009Rx only 190811prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-10-233548680159
8ab497fd8-00c3-4364-b003-b39d21fbdf38 (view SPL)Probenecid Tablets, USP500 mg Rx onlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-164005271367
9ae126418-5474-4fbe-b83c-bde8b2b4ae6e (view SPL)Probenecid Tablets USP Revised: June 2009Rx only 190811prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-06-114005915347

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