Acetaminophen / butalbital / Caffeine Oral Capsule

Brand(s)
Capacet, Esgic, Fioricet, Margesic, Orbivan, Zebutal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nexgen Pharma, Inc. (2014-04-30)
Oldest Current Product
1986-03-17
License(s)
ANDA
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:BUTALBITAL:CAFFEINE
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE
SPL Active
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE
SPL Moiety
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL: CAFFEINE

product(s) by strength(s)

acetaminophen 300 mg / butalbital 50 mg / caffeine 40 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912640ANDAWatson Laboratories, Inc.2013-07-29ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040885ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35
2007227029ANDANexgen Pharma, Inc.2009-11-16ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040885611356c6-9cf6-4316-a9cb-e7756955755b
3525440080FioricetANDAActavis Pharma, Inc.2013-07-29ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040885c018be7d-f7b8-45e2-97b8-8e7a71740657
4597020661OrbivanANDAAtley Pharmaceuticals, Inc.2010-04-23ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040885d3c69436-a681-4e00-8db0-8cbfaac9627e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910181ANDAAvkare, Inc.2014-11-24ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULE005912640ANDA040885f5bbad36-6a0e-3518-3f12-138ae9f63980
2650840454FioricetANDARxpak Division Of Mckesson Corporation2013-07-29ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULE525440080ANDA0408855d248332-87ff-45c2-be92-e9e8386a4749

acetaminophen 325 mg / butalbital 50 mg / caffeine 40 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005350012EsgicANDAForest Laboratories, Inc.1997-04-09ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA0890078aa576ac-c870-4ac0-a9a5-5539b38f653d
2006820804MargesicANDAMarnel Pharmaceuticals, Inc.1994-06-01ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007338b9f27-7097-4675-9ec5-e1eea6898cd5
3466720228ANDAMikart, Inc.1986-03-17ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007b151e4eb-bb9a-41b9-98a4-2e12bb4e2e5f
4518620179ANDALibertas Pharma, Inc.2012-04-16ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007fa88f437-830b-48bc-a44c-fd142963a150
5584070534CapacetANDAMagna Pharmaceuticals, Inc.2011-05-02ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007f3a37ce1-5082-4ac4-88a2-c8fadbd0b7b3
6683080219EsgicANDAMayne Pharma Inc.2014-05-01ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007c5827155-c339-4f7e-829b-6cf4edc581af
7683080554ZebutalANDAMayne Pharma Inc.2013-12-26ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA089007ac7e8ce7-088f-4d9c-ad52-2af60436d836

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001430170ANDAWest-Ward Pharmaceutical Corp1998-10-28ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA04026107b47cba-fadc-437e-9a9a-845ee1cce591
2596300170ZebutalANDAShionogi Inc.1998-10-28ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040261692a38bd-4588-4f9c-8def-59484c4ce425
3684530170ANDAVictory Pharmaceutical1998-10-28ACETAMINOPHEN, BUTALBITAL, CAFFEINEORALCAPSULEANDA040261c8328545-437a-4591-8cdc-66d275938024

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040085ESGIC-PLUSTrueMIKART INC1996-03-28ANDA040085_001
2ANDA040261BUTALBITAL, ACETAMINOPHEN AND CAFFEINETrueHIKMA PHARMACEUTICALS LLC1998-10-28ANDA040261_001
3ANDA040885BUTALBITAL, ACETAMINOPHEN AND CAFFEINENEXGEN PHARMA INC2009-11-16ANDA040885_001
4ANDA087628ANOQUANTrueSHIRE DEVELOPMENT INC1986-10-01ANDA087628_001
5ANDA088743BUTALBITAL, ACETAMINOPHEN AND CAFFEINETrueDM GRAHAM LABORATORIES INC1985-07-18ANDA088743_001
6ANDA088758BUTALBITAL, ACETAMINOPHEN AND CAFFEINETrueMALLINCKRODT CHEMICAL INC1985-03-27ANDA088758_001
7ANDA088765BUTALBITAL, ACETAMINOPHEN AND CAFFEINETrueDM GRAHAM LABORATORIES INC1985-03-27ANDA088765_001
8ANDA088825BUTALIBITAL, ACETAMINOPHEN AND CAFFEINETrueGILBERT LABORATORIES1984-12-05ANDA088825_001
9ANDA089007BUTALBITAL, ACETAMINOPHEN AND CAFFEINEMIKART INC1986-03-17ANDA089007_001
10ANDA089023TRIADTrueMALLINCKRODT CHEMICAL INC1985-06-19ANDA089023_001
11ANDA089067BUTALBITAL, ACETAMINOPHEN AND CAFFEINETrueDM GRAHAM LABORATORIES INC1985-04-19ANDA089067_001
12ANDA089102FEMCETTrueMALLINCKRODT CHEMICAL INC1985-06-19ANDA089102_001
13ANDA089115MEDIGESIC PLUSTrueUS CHEMICAL MARKETING GROUP INC1986-01-14ANDA089115_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040085_001discontinuedACETAMINOPHEN (500MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1996-03-28ESGIC-PLUS
2ANDA040261_001discontinuedCAFFEINE (40MG), BUTALBITAL (50MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1998-10-28BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
3ANDA040885_001RXACETAMINOPHEN (300MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULETrue2009-11-16BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
4ANDA087628_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1986-10-01ANOQUAN
5ANDA088743_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1985-07-18BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
6ANDA088758_001discontinuedBUTALBITAL (50MG), CAFFEINE (40MG), ACETAMINOPHEN (325MG)ORALCAPSULEFalse1985-03-27BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
7ANDA088765_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1985-03-27BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
8ANDA088825_001discontinuedBUTALBITAL (50MG), ACETAMINOPHEN (325MG), CAFFEINE (40MG)ORALCAPSULEFalse1984-12-05BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
9ANDA089007_001RXCAFFEINE (40MG), ACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALCAPSULETrue1986-03-17BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
10ANDA089023_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1985-06-19TRIAD
11ANDA089067_001discontinuedCAFFEINE (40MG), ACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALCAPSULEFalse1985-04-19BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
12ANDA089102_001discontinuedBUTALBITAL (50MG), CAFFEINE (40MG), ACETAMINOPHEN (325MG)ORALCAPSULEFalse1985-06-19FEMCET
13ANDA089115_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalse1986-01-14MEDIGESIC PLUS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
107b47cba-fadc-437e-9a9a-845ee1cce591 (view SPL)Butalbital, Acetaminophen, and Caffeine CapsulesprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2013-11-191001430170
2338b9f27-7097-4675-9ec5-e1eea6898cd5 (view SPL)prescriptionHuman PrescriptionMarnel Pharmaceuticals, Inc.2015-04-273006820804
35d248332-87ff-45c2-be92-e9e8386a4749 (view SPL)Fioricet CapsulesprescriptionHuman PrescriptionRxpak Division Of Mckesson CorporationREPACK2014-03-172650840454
4611356c6-9cf6-4316-a9cb-e7756955755b (view SPL)Butalbital, Acetaminophen, and Caffeine Capsules Rx onlyprescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-04-303007227029
5692a38bd-4588-4f9c-8def-59484c4ce425 (view SPL)Zebutal Capsules Brand of Butalbital, Acetaminophen, andCaffeine Capsules,USP Rx Only Rev. 09/11prescriptionHuman PrescriptionShionogi Inc.MANUFACTURE2011-11-0822596300170
68aa576ac-c870-4ac0-a9a5-5539b38f653d (view SPL)prescriptionHuman PrescriptionForest Laboratories, Inc.MANUFACTURE2013-09-022005350012
7ac7e8ce7-088f-4d9c-ad52-2af60436d836 (view SPL)prescriptionHuman PrescriptionMayne Pharma Inc.2014-01-231683080554
8b151e4eb-bb9a-41b9-98a4-2e12bb4e2e5f (view SPL)prescriptionHuman PrescriptionMikart, Inc.2013-09-023466720228
9c018be7d-f7b8-45e2-97b8-8e7a71740657 (view SPL)Fioricet CapsulesprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-024525440080
10c5827155-c339-4f7e-829b-6cf4edc581af (view SPL)prescriptionHuman PrescriptionMayne Pharma Inc.2015-09-232683080219
11c8328545-437a-4591-8cdc-66d275938024 (view SPL)Zebutal Capsules Brand of Butalbital, Acetaminophen, andCaffeine Capsules,USP Rx Only Rev. 05/11prescriptionHuman PrescriptionVictory PharmaceuticalMANUFACTURE2011-07-0112684530170
12d3c69436-a681-4e00-8db0-8cbfaac9627e (view SPL)Butalbital, Acetaminophen, and Caffeine CapsulesRx onlyprescriptionHuman PrescriptionAtley Pharmaceuticals, Inc.2010-04-231597020661
13ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35 (view SPL)Butalbital, Acetaminophen, and Caffeine Capsules, USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-024005912640
14f3a37ce1-5082-4ac4-88a2-c8fadbd0b7b3 (view SPL)prescriptionHuman PrescriptionMagna Pharmaceuticals, Inc.2013-09-023584070534
15f5bbad36-6a0e-3518-3f12-138ae9f63980 (view SPL)Butalbital, Acetaminophen, and Caffeine Capsules, USPprescriptionHuman PrescriptionAvkare, Inc.2015-01-292422910181
16fa88f437-830b-48bc-a44c-fd142963a150 (view SPL)prescriptionHuman PrescriptionLibertas Pharma, Inc.2013-11-082518620179

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