Aspirin / butalbital / Caffeine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Major (2014-10-15)
Oldest Current Product
1979-06-05
License(s)
ANDA
RxNORM
ORAL TABLET\ASPIRIN:BUTALBITAL:CAFFEINE
FDAOB
ORAL\CAPSULE\ASPIRIN: BUTALBITAL: CAFFEINE
ORAL\TABLET\ASPIRIN: BUTALBITAL: CAFFEINE
SPL Active
ORAL\TABLET\ASPIRIN: BUTALBITAL: CAFFEINE
SPL Moiety
ORAL\TABLET\ASPIRIN: BUTALBITAL: CAFFEINE

product(s) by strength(s)

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

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431785ANDAWest-Ward Pharmaceutical Corp1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLETANDA086162cae6b59d-13dc-49ea-ad4b-2f2bdae23840
2009043892ANDAMajor2000-01-28ASPIRIN, BUTALBITAL, CAFFEINEORALTABLETANDA0861622ad8bd05-c133-45f5-9100-11660ec40043

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950354ANDARebel Distributors Corp2009-12-15ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA0861624e10129b-41a3-4572-9564-6f8366b627dc
2499990115ANDALake Erie Medical Dba Quality Care Products Llc2012-02-23ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA086162e40e3f1c-ff0e-433d-99e5-8882575fca38
3529590370ANDAH.J. Harkins Company, Inc.1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431787ANDA0861622ef4b16c-f553-4a79-b5ee-7893aeb0eae3
4545690339ANDAA-S Medication Solutions Llc1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA086162b91dd287-db2b-4c5a-b255-a355bc7ba97a
5552890040ANDAPd-Rx Pharmaceuticals, Inc.1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA0861626e0de6e8-e72f-4491-a3f0-657a24c4fc99
6636292951ANDABryant Ranch Prepack1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA086162bf2b6445-be65-4418-8118-e5a878ad9f41
7663360619ANDADispensing Solutions, Inc.1979-06-05ASPIRIN, BUTALBITAL, CAFFEINEORALTABLET001431785ANDA086162657e4c4a-e50c-49f7-99b4-32395ec19bd8

application(s)

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

application drug(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12ad8bd05-c133-45f5-9100-11660ec40043 (view SPL)Butalbital Aspirin and Caffeine TabletsprescriptionHuman PrescriptionMajor2014-10-152009043892
22ef4b16c-f553-4a79-b5ee-7893aeb0eae3 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-01-032529590370
34e10129b-41a3-4572-9564-6f8366b627dc (view SPL)Butalbital, Aspirin, and Caffeine Tablets, USP CIIIRev. 04/03Rx OnlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-101216950354
4657e4c4a-e50c-49f7-99b4-32395ec19bd8 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-292663360619
56e0de6e8-e72f-4491-a3f0-657a24c4fc99 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-06-1111552890040
6b91dd287-db2b-4c5a-b255-a355bc7ba97a (view SPL)Butalbital, Aspirin and Caffeine Tablets, USP CII Rx Only Rev. 01/12prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-04-241545690339
7bf2b6445-be65-4418-8118-e5a878ad9f41 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USP CII Rx Only Rev. 01/12prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636292951
8cae6b59d-13dc-49ea-ad4b-2f2bdae23840 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USP CII Rx Only Rev. 01/12prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2012-01-2612001431785
9e40e3f1c-ff0e-433d-99e5-8882575fca38 (view SPL)Butalbital, Aspirin and Caffeine Tablets, USP CIII Rx Only Rev. 01/12prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-02-233586499990115

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