Aspirin / butalbital / Caffeine / Codeine Oral Capsule

Brand(s)
Ascomp, Fiorinal with Codeine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-09-10)
Oldest Current Product
1990-10-26
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ASPIRIN:BUTALBITAL:CAFFEINE:CODEINE
FDAOB
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE: CODEINE PHOSPHATE
SPL Active
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE: CODEINE PHOSPHATE
SPL Moiety
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE: CODEINE
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE: CODEINE ANHYDROUS

product(s) by strength(s)

aspirin 325 mg / butalbital 50 mg / caffeine 40 mg / codeine phosphate 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440956Fiorinal with CodeineNDAActavis Pharma, Inc.1990-10-26ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULENDA019429ace223cc-458e-4455-a64e-83e5cbf95f9a

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913546NDA AUTHORIZED GENERICWatson Laboratories, Inc.2006-10-26ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULENDA019429ad135f46-5490-40e9-9add-1a953c6d6a9d
2007226094AscompANDANexgen Pharma, Inc.2001-11-30ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA075231ca3fe6e9-21ad-4fba-a602-e1c364cf3981
3519910074AscompANDABreckenridge Pharmaceutical, Inc.2009-05-01ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA075231243a6aea-0f48-42a9-a85e-ff247ab94336
4683080312ANDAMayne Pharma Inc.2015-10-30ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA2033353dd63865-af88-4cfe-a028-a21b3e65c25d

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681037ANDAPhysicians Total Care, Inc.1998-06-02ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE005913546ANDA074359787cda7d-7aa4-4909-8e5c-f2fcf68828e4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1005271312ANDALannett Company, Inc.1998-08-31ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE505640507ANDA07495104bddbc4-86c7-4bac-9327-010568020568
2500900103NDA AUTHORIZED GENERICA-S Medication Solutions Llc2006-10-26ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE005913546NDA01942966305a0c-caf8-414a-a30b-3ab7b73086e1
3545690337NDA AUTHORIZED GENERICA-S Medication Solutions Llc2006-10-26ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE005913546NDA019429850bfccf-be34-423a-88d1-eba72f10434b
4636292952ANDABryant Ranch Prepack2010-03-30ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE519910074ANDA07523195a33c9b-79a6-47c7-8433-fc217950b88f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074359BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATETrueWATSON LABORATORIES INC1995-08-31ANDA074359_001
2ANDA074951BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEJEROME STEVENS PHARMACEUTICALS INC1998-08-31ANDA074951_001
3ANDA075231BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATENEXGEN PHARMA INC2001-11-30ANDA075231_001
4ANDA075351BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATETrueVINTAGE PHARMACEUTICALS LLC1999-03-05ANDA075351_001
5ANDA203335BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATECOASTAL PHARMACEUTICALS2015-10-30ANDA203335_001
6NDA019429FIORINAL W/CODEINEACTAVIS LABORATORIES UT INC1990-10-26NDA019429_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074359_001discontinuedASPIRIN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG), CODEINE PHOSPHATE (30MG)ORALCAPSULEFalse1995-08-31BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
2ANDA074951_001RXCODEINE PHOSPHATE (30MG), BUTALBITAL (50MG), CAFFEINE (40MG), ASPIRIN (325MG)ORALCAPSULEFalseAB1998-08-31BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
3ANDA075231_001RXBUTALBITAL (50MG), CAFFEINE (40MG), CODEINE PHOSPHATE (30MG), ASPIRIN (325MG)ORALCAPSULEFalseAB2001-11-30BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
4ANDA075351_001discontinuedASPIRIN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG), CODEINE PHOSPHATE (30MG)ORALCAPSULEFalse1999-03-05BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
5ANDA203335_001RXCODEINE PHOSPHATE (30MG), BUTALBITAL (50MG), ASPIRIN (325MG), CAFFEINE (40MG)ORALCAPSULEFalseAB2015-10-30BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
6NDA019429_003RXCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG), CODEINE PHOSPHATE (30MG)ORALCAPSULETrueAB1990-10-26FIORINAL W/CODEINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104bddbc4-86c7-4bac-9327-010568020568 (view SPL)BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULES, USPCIIIRx ONLYprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-05-0410005271312
2243a6aea-0f48-42a9-a85e-ff247ab94336 (view SPL)Ascomp with Codeine (Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules, USP)prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2009-10-161519910074
33dd63865-af88-4cfe-a028-a21b3e65c25d (view SPL)Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USPprescriptionHuman PrescriptionMayne Pharma Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-103683080312
466305a0c-caf8-414a-a30b-3ab7b73086e1 (view SPL)Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USPC-IIIContent Updated: February 2014 Rx only191097-2prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-141500900103
5787cda7d-7aa4-4909-8e5c-f2fcf68828e4 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-291548681037
6850bfccf-be34-423a-88d1-eba72f10434b (view SPL)Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USPC-IIIContent Updated: February 2014 Rx only191097-2prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545690337
795a33c9b-79a6-47c7-8433-fc217950b88f (view SPL)butalbital, aspirin, caffeine and codeine phosphate capsuleprescriptionHuman PrescriptionBryant Ranch Prepackrepack2012-10-122636292952
8ace223cc-458e-4455-a64e-83e5cbf95f9a (view SPL)Fiorinal with Codeine C-III(Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) Content Updated: February 2014 Rx only 191100-2prescriptionHuman PrescriptionActavis Pharma, Inc.2014-09-1010525440956
9ad135f46-5490-40e9-9add-1a953c6d6a9d (view SPL)Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USPC-IIIContent Updated: February 2014 Rx only191097-2prescriptionHuman PrescriptionWatson Laboratories, Inc.2014-09-039005913546
10ca3fe6e9-21ad-4fba-a602-e1c364cf3981 (view SPL)Ascomp with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) CapsuleprescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-07-152007226094

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