Acetaminophen / Caffeine / dihydrocodeine Oral Capsule

Brand(s)
Trezix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wraser Pharmaceuticals (2014-12-01)
Oldest Current Product
2009-09-01
License(s)
ANDA
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:CAFFEINE:DIHYDROCODEINE
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Active
ORAL\CAPSULE\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Moiety
ORAL\CAPSULE\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE

product(s) by strength(s)

acetaminophen 320.5 mg / caffeine 30 mg / dihydrocodeine bitartrate 16 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1421950840ANDAXspire Pharma2015-08-05ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULEANDA20478576e033b0-01c1-42df-bb64-f8ca401cfb6b
2669920840TrezixANDAWraser Pharmaceuticals2014-12-01ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULEANDA204785a519a201-bcfd-4029-9bdf-fc3e03f975ac

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1669920340TrezixANDAWraser Pharmaceuticals2009-09-01ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULEANDA04068863841f53-a567-4102-80b5-3565d9b52373

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1458650866Medsource PharmaceuticalsACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULE42195084020c699bc-0d62-5984-e054-00144ff88e88
2687888918ANDAPreferred Pharmaceuticals, Inc.2015-09-11ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULE421950840ANDA2047851002a53c-551c-48f3-b4a5-a0922e1e8ca7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040109ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATETrueMIKART INC1997-08-26ANDA040109_001
2ANDA040688ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATETrueWRASER PHARMACEUTICALS LLC2007-04-03ANDA040688_001
3ANDA088584DHC PLUSTruePHARMACEUTICAL RESEARCH ASSOC INC1986-03-04ANDA088584_001
4ANDA089166SYNALGOS-DC-ATrueLEITNER PHARMACEUTICALS LLC1986-05-14ANDA089166_001
5ANDA204785TREZIXWRASER PHARMACEUTICALS LLC2014-11-26ANDA204785_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040109_001discontinuedDIHYDROCODEINE BITARTRATE (16MG), CAFFEINE (30MG), ACETAMINOPHEN (356.4MG)ORALCAPSULEFalse1997-08-26ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
2ANDA040688_001discontinuedDIHYDROCODEINE BITARTRATE (16MG), CAFFEINE (30MG), ACETAMINOPHEN (356.4MG)ORALCAPSULEFalse2007-04-03ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
3ANDA088584_001discontinuedDIHYDROCODEINE BITARTRATE (16MG), ACETAMINOPHEN (356.4MG), CAFFEINE (30MG)ORALCAPSULEFalse1986-03-04DHC PLUS
4ANDA089166_001discontinuedDIHYDROCODEINE BITARTRATE (16MG), ACETAMINOPHEN (356.4MG), CAFFEINE (30MG)ORALCAPSULEFalse1986-05-14SYNALGOS-DC-A
5ANDA204785_001RXDIHYDROCODEINE BITARTRATE (16MG), ACETAMINOPHEN (320.5MG), CAFFEINE (30MG)ORALCAPSULEFalse2014-11-26TREZIX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11002a53c-551c-48f3-b4a5-a0922e1e8ca7 (view SPL)Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CapsulesprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-09-111687888918
220c699bc-0d62-5984-e054-00144ff88e88 (view SPL)Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CapsulesprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-09-271458650866
363841f53-a567-4102-80b5-3565d9b52373 (view SPL)TREZIX CapsulesprescriptionHuman PrescriptionWraser Pharmaceuticals2011-07-012669920340
476e033b0-01c1-42df-bb64-f8ca401cfb6b (view SPL)Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CapsulesprescriptionHuman PrescriptionXspire Pharmamanufacture2015-08-111421950840
5a519a201-bcfd-4029-9bdf-fc3e03f975ac (view SPL)TREZIX CapsulesprescriptionHuman PrescriptionWraser Pharmaceuticalsmanufacture2014-12-011669920840

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