Aspirin / butalbital / Caffeine Oral Capsule

Brand(s)
Fiorinal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-09-08)
Oldest Current Product
1976-05-04
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ASPIRIN:BUTALBITAL:CAFFEINE
FDAOB
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE
ORAL\TABLET\ASPIRIN: BUTALBITAL: CAFFEINE
SPL Active
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE
SPL Moiety
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE

product(s) by strength(s)

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

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440955FiorinalNDAActavis Pharma, Inc.1976-05-04ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULENDA017534a00c6776-e9ef-411b-9396-915c3787559a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271552ANDALannett Company, Inc.1985-10-11ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULEANDA086996ba60b130-33cd-4db9-92a7-2cab8ded0737
2005913219NDA AUTHORIZED GENERICWatson Laboratories, Inc.2003-10-06ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULENDA017534e31096f4-162f-44bd-a211-9c2873acfe54

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950139ANDARebel Distributors Corp2003-09-18ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219ANDA086231aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900911NDA AUTHORIZED GENERICStat Rx Usa Llc1976-05-04ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA017534c69954d9-9b30-484f-8e4a-5b1fc7dd197d
2332610922NDA AUTHORIZED GENERICAidarex Pharmaceuticals Llc1976-05-04ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA017534166e131d-9c1a-461f-bf33-e45d4ec36ff2
3500901464NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-10-06ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA0175349286d77c-feda-48a0-a04b-5fd9879e5fe0
4500901465NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-10-06ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA0175345cd45280-2b8c-4ba8-bde9-db687d96847f
5545696554NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-10-06ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA01753439c7d9f4-9889-4136-bc09-8e5540cd9144
6545698372NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-10-06ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA0175349771b178-cdcd-4992-a066-d7e18e9a5e44
7557000129ANDALake Erie Medical Dba Quality Care Products Llc1985-10-11ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005271552ANDA086996e334b580-ffc9-4ec7-836b-31b2211c730f
8680840934NDA AUTHORIZED GENERICAmerican Health Packaging2015-03-31ASPIRIN, BUTALBITAL, CAFFEINEORALCAPSULE005913219NDA017534c34588ef-a580-4a8b-a525-808e956a4056

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA078149BUTALBITAL, ASPIRIN AND CAFFEINETrueMUTUAL PHARMACEUTICAL CO INC2007-06-13ANDA078149_001
2ANDA085441BUTALBITAL, ASPIRIN AND CAFFEINETrueIVAX PHARMACEUTICALS INC1984-10-31ANDA085441_002Aspirin / butalbital / Caffeine Oral Tablet
3ANDA086162BUTALBITAL, ASPIRIN AND CAFFEINEHIKMA INTERNATIONAL PHARMACEUTICALS LLC1984-02-16ANDA086162_002Aspirin / butalbital / Caffeine Oral Tablet
4ANDA086231BUTALBITAL, ASPIRIN AND CAFFEINETrueWATSON LABORATORIES INC1985-02-12ANDA086231_002
5ANDA086237BUTALBITAL, ASPIRIN AND CAFFEINETrueWATSON LABORATORIES INC1984-03-23ANDA086237_002Aspirin / butalbital / Caffeine Oral Tablet
6ANDA086398BUTALBITAL, ASPIRIN AND CAFFEINETrueSANDOZ INC1984-04-06ANDA086398_002Aspirin / butalbital / Caffeine Oral Tablet
7ANDA086710BUTALBITAL, ASPIRIN AND CAFFEINETrueACTAVIS ELIZABETH LLC1983-08-23ANDA086710_002Aspirin / butalbital / Caffeine Oral Tablet
8ANDA086986LANORINALTrueLANNETT CO INC1985-10-18ANDA086986_002Aspirin / butalbital / Caffeine Oral Tablet
9ANDA086996LANORINALLANNETT CO INC1985-10-11ANDA086996_002
10ANDA087048BUTALBITAL, ASPIRIN AND CAFFEINETruePURACAP PHARMACEUTICAL LLC1983-12-09ANDA087048_002Aspirin / butalbital / Caffeine Oral Tablet
11ANDA088972BUTALBITAL, ASPIRIN AND CAFFEINETrueQUANTUM PHARMICS LTD1985-06-18ANDA088972_001Aspirin / butalbital / Caffeine Oral Tablet
12ANDA089448BUTALBITAL, ASPIRIN AND CAFFEINETrueHALSEY DRUG CO INC1986-12-01ANDA089448_001Aspirin / butalbital / Caffeine Oral Tablet
13NDA017534FIORINALACTAVIS LABORATORIES UT INC1986-04-16NDA017534_003, NDA017534_005Aspirin / butalbital / Caffeine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078149_001discontinuedBUTALBITAL (50MG), CAFFEINE (40MG), ASPIRIN (325MG)ORALCAPSULEFalse2007-06-13BUTALBITAL, ASPIRIN AND CAFFEINE
2ANDA085441_002discontinuedCAFFEINE (40MG), BUTALBITAL (50MG), ASPIRIN (325MG)ORALTABLETFalse1984-10-31BUTALBITAL, ASPIRIN AND CAFFEINE
3ANDA086162_002RXASPIRIN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALTABLETTrueAA1984-02-16BUTALBITAL, ASPIRIN AND CAFFEINE
4ANDA086231_002discontinuedCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG)ORALCAPSULEFalse1985-02-12BUTALBITAL, ASPIRIN AND CAFFEINE
5ANDA086237_002discontinuedCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1984-03-23BUTALBITAL, ASPIRIN AND CAFFEINE
6ANDA086398_002discontinuedASPIRIN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALTABLETFalse1984-04-06BUTALBITAL, ASPIRIN AND CAFFEINE
7ANDA086710_002discontinuedBUTALBITAL (50MG), CAFFEINE (40MG), ASPIRIN (325MG)ORALTABLETFalse1983-08-23BUTALBITAL, ASPIRIN AND CAFFEINE
8ANDA086986_002discontinuedCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1985-10-18LANORINAL
9ANDA086996_002RXASPIRIN (325MG), BUTALBITAL (50MG), CAFFEINE (40MG)ORALCAPSULEFalseAA1985-10-11LANORINAL
10ANDA087048_002discontinuedASPIRIN (325MG), CAFFEINE (40MG), BUTALBITAL (50MG)ORALTABLETFalse1983-12-09BUTALBITAL, ASPIRIN AND CAFFEINE
11ANDA088972_001discontinuedBUTALBITAL (50MG), ASPIRIN (325MG), CAFFEINE (40MG)ORALTABLETFalse1985-06-18BUTALBITAL, ASPIRIN AND CAFFEINE
12ANDA089448_001discontinuedCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1986-12-01BUTALBITAL, ASPIRIN AND CAFFEINE
13NDA017534_003discontinuedCAFFEINE (40MG), ASPIRIN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1986-04-16FIORINAL
14NDA017534_005RXBUTALBITAL (50MG), CAFFEINE (40MG), ASPIRIN (325MG)ORALCAPSULETrueAA1986-04-16FIORINAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1166e131d-9c1a-461f-bf33-e45d4ec36ff2 (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIRevised: June 2009 Rx only 1901100609prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-231332610922
239c7d9f4-9889-4136-bc09-8e5540cd9144 (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIContent Updated: February 2014Rx only190110-1prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545696554
35cd45280-2b8c-4ba8-bde9-db687d96847f (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIContent Updated: February 2014Rx only190110-1prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500901465
49286d77c-feda-48a0-a04b-5fd9879e5fe0 (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIContent Updated: February 2014Rx only190110-1prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500901464
59771b178-cdcd-4992-a066-d7e18e9a5e44 (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIContent Updated: February 2014Rx only190110-1prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545698372
6a00c6776-e9ef-411b-9396-915c3787559a (view SPL)Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) C-IIIRevised: February 2014 Rx only 190104-1prescriptionHuman PrescriptionActavis Pharma, Inc.2014-09-086525440955
7aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0 (view SPL)Butalbital, Aspirin, and Caffeine CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-201216950139
8ba60b130-33cd-4db9-92a7-2cab8ded0737 (view SPL)Butalbital, Aspirin, and Caffeine Capsules CIIIRx OnlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-11-037005271552
9c34588ef-a580-4a8b-a525-808e956a4056 (view SPL)Butalbital, Aspirin, and Caffeine Capsules USP CIIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-191680840934
10c69954d9-9b30-484f-8e4a-5b1fc7dd197d (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIRevised: June 2009 Rx only 1901100609prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-09-221165900911
11e31096f4-162f-44bd-a211-9c2873acfe54 (view SPL)Butalbital, Aspirin, and Caffeine Capsules, USP C-IIIContent Updated: February 2014Rx only190110-1prescriptionHuman PrescriptionWatson Laboratories, Inc.2014-09-035005913219
12e334b580-ffc9-4ec7-836b-31b2211c730f (view SPL)Butalbital, Aspirin, and Caffeine Capsules CIIIRx OnlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-07-061557000129

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