Pyrimethamine Oral Tablet

Brand(s)
Daraprim
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Turing Pharmaceuticals Llc (2015-09-28)
Oldest Current Product
1953-01-23
License(s)
NDA
RxNORM
ORAL TABLET\PYRIMETHAMINE
FDAOB
ORAL\TABLET\PYRIMETHAMINE
SPL Active
ORAL\TABLET\PYRIMETHAMINE
SPL Moiety
ORAL\TABLET\PYRIMETHAMINE

product(s) by strength(s)

pyrimethamine 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1694130330DaraprimNDATuring Pharmaceuticals Llc1953-01-23PYRIMETHAMINEORALTABLETNDA0085785368616d-6520-6f6e-2053-686b72656c69

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790090DaraprimNDAKaiser Foundations Hospitals2011-04-20PYRIMETHAMINEORALTABLET520540330NDA0085783a8cac03-0cb6-4c70-aae2-842020985768
2521250003DaraprimNDARemedyrepack Inc.2013-02-26PYRIMETHAMINEORALTABLET520540330NDA0085784f82eaa3-07e5-41ac-8db9-944ac4c93585

application(s)

#idtitleapplicantapproved drug
1NDA008578DARAPRIMTURING PHARMACEUTICALS AGNDA008578_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1NDA008578_001RXPYRIMETHAMINE (25MG)ORALTABLETTrueDARAPRIM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13a8cac03-0cb6-4c70-aae2-842020985768 (view SPL)DARAPRIM (pyrimethamine)25-mg Scored TabletsprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2011-04-251001790090
23e4d5027-7939-480f-ae19-82e764d9fa97 (view SPL)DARAPRIM (pyrimethamine)25-mg Scored TabletsRx OnlyprescriptionHuman PrescriptionAmedra Pharmaceuticals Llc2014-10-315520540330
34f82eaa3-07e5-41ac-8db9-944ac4c93585 (view SPL)DARAPRIM(pyrimethamine)25-mg Scored TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-261521250003
45368616d-6520-6f6e-2053-686b72656c69 (view SPL)prescriptionHuman PrescriptionTuring Pharmaceuticals LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-282694130330

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