Acetaminophen / butalbital / Caffeine / Codeine Oral Capsule

Brand(s)
Fioricet with Codeine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2015-08-07)
Oldest Current Product
2001-03-21
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:BUTALBITAL:CAFFEINE:CODEINE
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE: CODEINE PHOSPHATE
SPL Active
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE: CODEINE PHOSPHATE
SPL Moiety
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE: CODEINE
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE: CODEINE ANHYDROUS

product(s) by strength(s)

acetaminophen 300 mg / butalbital 50 mg / caffeine 40 mg / codeine phosphate 30 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912641ANDAWatson Laboratories, Inc.2013-07-29ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA07656052321fe5-c001-4e2d-8149-3197ddc13764
2007227028ANDANexgen Pharma, Inc.2012-07-20ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA0765608f8c5c01-5859-4843-adf4-8116ddaedc90
3525440082Fioricet with CodeineANDAActavis Pharma, Inc.2013-07-29ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA076560df9801fc-03fe-41da-a6b3-0f76788217c9

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

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001433000ANDAWest-Ward Pharmaceutical Corp2001-03-21ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA075618410527dc-b93d-4efb-9528-ca58b98d851f
2005913220NDA AUTHORIZED GENERICWatson Laboratories, Inc.2003-10-01ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULENDA020232a58819b8-a52c-44a7-9ab0-c74480d98506
3006032553ANDAQualitest Pharmaceuticals2002-04-22ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA0759296f8cced0-4749-4a11-8f00-96d8c23c1cfd
4007226670ANDANexgen Pharma, Inc.2004-06-10ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA0765608c1edb39-1ae9-44f1-b23b-387b715a3df6
5519910073ANDABreckenridge Pharmaceutical, Inc.2004-07-01ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULEANDA076560d74db417-d2de-495b-bb75-46a83745603d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685162NDAPhysicians Total Care, Inc.2009-07-06ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE005913220NDA020232908bdfc3-ac28-44c9-aa59-39e7b9b28903
2636293152NDA AUTHORIZED GENERICBryant Ranch Prepack2003-07-13ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE005913220NDA0202323f0c092b-08db-4e8f-136a-456e0e7bec14
3682582012ANDADispensing Solutions, Inc.2004-07-01ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATEORALCAPSULE519910073ANDA0765607fd761e6-64fe-44cc-8b74-10ce31ccfd66

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074911PHRENILIN WITH CAFFEINE AND CODEINETrueVALEANT PHARMACEUTICALS INTERNATIONAL2001-08-22ANDA074911_001
2ANDA075618BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEHIKMA INTERNATIONAL PHARMACEUTICALS LLC2001-03-23ANDA075618_001
3ANDA075929BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEVINTAGE PHARMACEUTICALS INC2002-04-22ANDA075929_001
4ANDA076528BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATETrueABLE LABORATORIES INC2003-08-21ANDA076528_001
5ANDA076560BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATENEXGEN PHARMA INC2004-06-10ANDA076560_001, ANDA076560_002
6NDA020232FIORICET W/ CODEINEACTAVIS LABORATORIES UT INC1992-07-30NDA020232_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074911_001discontinuedCODEINE PHOSPHATE (30MG), ACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse2001-08-22PHRENILIN WITH CAFFEINE AND CODEINE
2ANDA075618_001RXACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG), CODEINE PHOSPHATE (30MG)ORALCAPSULEFalseAB2001-03-23BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
3ANDA075929_001RXACETAMINOPHEN (325MG), BUTALBITAL (50MG), CODEINE PHOSPHATE (30MG), CAFFEINE (40MG)ORALCAPSULEFalseAB2002-04-22BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
4ANDA076528_001discontinuedACETAMINOPHEN (325MG), CAFFEINE (40MG), BUTALBITAL (50MG), CODEINE PHOSPHATE (30MG)ORALCAPSULEFalse2003-08-21BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
5ANDA076560_001RXACETAMINOPHEN (325MG), CODEINE PHOSPHATE (30MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalseAB2004-06-10BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
6ANDA076560_002RXCODEINE PHOSPHATE (30MG), CAFFEINE (40MG), BUTALBITAL (50MG), ACETAMINOPHEN (300MG)ORALCAPSULEFalse2012-07-19BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
7NDA020232_001RXACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG), CODEINE PHOSPHATE (30MG)ORALCAPSULETrueAB1992-07-30FIORICET W/ CODEINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13f0c092b-08db-4e8f-136a-456e0e7bec14 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules C-IIIRevised: March 2009Rx only1841810309prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293152
2410527dc-b93d-4efb-9528-ca58b98d851f (view SPL)BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE WITH CODEINE PHOSPHATE CAPSULES CIII Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-10-1612001433000
352321fe5-c001-4e2d-8149-3197ddc13764 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-303005912641
46f8cced0-4749-4a11-8f00-96d8c23c1cfd (view SPL)BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULESprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-09-1813006032553
57fd761e6-64fe-44cc-8b74-10ce31ccfd66 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules CIIIprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-032682582012
68c1edb39-1ae9-44f1-b23b-387b715a3df6 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesprescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-016007226670
78f8c5c01-5859-4843-adf4-8116ddaedc90 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesprescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-07-016007227028
8908bdfc3-ac28-44c9-aa59-39e7b9b28903 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-223548685162
9a58819b8-a52c-44a7-9ab0-c74480d98506 (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules C-III Content Updated: August 2014 Rx only 184181-5prescriptionHuman PrescriptionWatson Laboratories, Inc.2015-08-0721005913220
10d74db417-d2de-495b-bb75-46a83745603d (view SPL)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules CIIIprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2009-10-202519910073
11df9801fc-03fe-41da-a6b3-0f76788217c9 (view SPL)Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) CapsulesprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-303525440082

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