mercaptopurine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-03-27)
Oldest Current Product
2004-02-11
License(s)
ANDA
RxNORM
ORAL TABLET\MERCAPTOPURINE
FDAOB
ORAL\TABLET\MERCAPTOPURINE
SPL Active
ORAL\TABLET\MERCAPTOPURINE
SPL Moiety
ORAL\TABLET\MERCAPTOPURINE
ORAL\TABLET\MERCAPTOPURINE ANHYDROUS

product(s) by strength(s)

mercaptopurine 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544581ANDARoxane Laboratories, Inc2004-02-13MERCAPTOPURINEORALTABLETANDA040528c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658
2003783547ANDAMylan Pharmaceuticals Inc.2005-07-14MERCAPTOPURINEORALTABLETANDA04059415904472-4c32-4224-95d3-eb131a7ff9c8
3498840922ANDAPar Pharmaceutical Companies, Inc.2004-02-11MERCAPTOPURINEORALTABLETANDA04046140b09616-5bb1-4ef8-98cd-d87537254296

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490606ANDARemedyrepack Inc.2011-11-03MERCAPTOPURINEORALTABLET000544581ANDA040528a1cb24ae-9b12-4c9b-a4bd-27d49b64d974
2548685282ANDAPhysicians Total Care, Inc.2005-05-23MERCAPTOPURINEORALTABLET498840922ANDA0404611db50d07-0326-4fb9-aa51-0a2493914e85
3680840325ANDAAmerican Health Packaging2013-03-15MERCAPTOPURINEORALTABLET498840922ANDA040461276e7d7e-49ca-483f-9f91-316381665c1b
4691894581ANDAAvera Mckennan Hospital2015-03-01MERCAPTOPURINEORALTABLET000544581ANDA040528585f2c78-7e67-4533-b75d-0de217e5f216

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040461MERCAPTOPURINEPROMETHEUS LABORATORIES INC2004-02-11ANDA040461_001
2ANDA040528MERCAPTOPURINEROXANE LABORATORIES INC2004-02-13ANDA040528_001
3ANDA040594MERCAPTOPURINEMYLAN PHARMACEUTICALS INC2005-07-01ANDA040594_001
4NDA009053PURINETHOLTrueTEVA PHARMACEUTICALS USA INCNDA009053_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040461_001RXMERCAPTOPURINE (50MG)ORALTABLETFalseAB2004-02-11MERCAPTOPURINE
2ANDA040528_001RXMERCAPTOPURINE (50MG)ORALTABLETTrueAB2004-02-13MERCAPTOPURINE
3ANDA040594_001RXMERCAPTOPURINE (50MG)ORALTABLETFalseAB2005-07-01MERCAPTOPURINE
4NDA009053_002discontinuedMERCAPTOPURINE (50MG)ORALTABLETFalsePURINETHOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115904472-4c32-4224-95d3-eb131a7ff9c8 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-03-147003783547
21db50d07-0326-4fb9-aa51-0a2493914e85 (view SPL)MERCAPTOPURINE TABLETS USP, 50 MG Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-10-013548685282
3276e7d7e-49ca-483f-9f91-316381665c1b (view SPL)MERCAPTOPURINE TABLETS USP, 50 MG Rx onlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-03-152680840325
440b09616-5bb1-4ef8-98cd-d87537254296 (view SPL)MERCAPTOPURINE TABLETS USP, 50 MG Rx onlyprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-01-076498840922
5585f2c78-7e67-4533-b75d-0de217e5f216 (view SPL)Mercaptopurine Tablets USP, 50 mgprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-10-291691894581
6a1cb24ae-9b12-4c9b-a4bd-27d49b64d974 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-11-031493490606
7c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658 (view SPL)Mercaptopurine Tablets USP, 50 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-03-276000544581

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