Acetaminophen / butalbital Oral Tablet

Brand(s)
Bupap, Marten-Tab, Phrenilin, Tencon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mikart, Inc. (2013-11-05)
Oldest Current Product
1992-10-26
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAMINOPHEN:BUTALBITAL
FDAOB
ORAL\TABLET\ACETAMINOPHEN: BUTALBITAL
SPL Active
ORAL\TABLET\ACETAMINOPHEN: BUTALBITAL
SPL Moiety
ORAL\TABLET\ACETAMINOPHEN: BUTALBITAL

product(s) by strength(s)

acetaminophen 300 mg / butalbital 50 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000953000BupapANDAEcr Pharmaceuticals2013-06-24ACETAMINOPHEN, BUTALBITALORALTABLETANDA09095630e483da-eaf1-4c73-9fed-333337f9ba86
2007227075ANDANexgen Pharma, Inc.2011-04-01ACETAMINOPHEN, BUTALBITALORALTABLETANDA090956669e3bd0-fbd9-423c-8654-a78fe650e3e2

acetaminophen 325 mg / butalbital 50 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006032540ANDAQualitest Pharmaceuticals1999-06-03ACETAMINOPHEN, BUTALBITALORALTABLETANDA089987e619b656-4123-4878-b601-b0edad3c428b
2006821400Marten-TabANDAMarnel Pharmaceuticals, Inc.1996-01-11ACETAMINOPHEN, BUTALBITALORALTABLETANDA08998785c7db7a-a99a-43ef-9337-9916762ca087
3115840030TenconANDAInternational Ethical Labs, Inc.2013-10-10ACETAMINOPHEN, BUTALBITALORALTABLETANDA0899874e4a9925-67aa-4be7-8bb7-c8b058ffe223
4466720099ANDAMikart, Inc.1992-10-26ACETAMINOPHEN, BUTALBITALORALTABLETANDA089987ca8a0862-1956-43ad-844d-77153aa09dfb

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001870842PhrenilinANDAValeant Pharmaceuticals North America Llc2004-05-032013-12-31ACETAMINOPHEN, BUTALBITALORALTABLETANDA087811a81c62d2-8151-42db-bda7-e08578ac5089

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1694990302ANDASolubiomix2015-10-10ACETAMINOPHEN, BUTALBITALORALTABLET006821400ANDA0899872cddfd28-6ce7-4708-8f11-6d4dc33fae5b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1425490495ANDAStat Rx Usa Llc1994-12-01ACETAMINOPHEN, BUTALBITALORALTABLET000950240ANDA089988be1b8109-725e-4427-9cd9-b468a71a48bd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087550BUTALBITAL AND ACETAMINOPHENTrueWATSON LABORATORIES INC1984-10-19ANDA087550_001
2ANDA087811PHRENILINTrueVALEANT PHARMACEUTICALS INTERNATIONAL1985-06-19ANDA087811_001
3ANDA088944SEDAPAPTrueMAYRAND INC1985-10-17ANDA088944_001
4ANDA089568BUTALBITAL AND ACETAMINOPHENTrueHALSEY DRUG CO INC1988-10-05ANDA089568_001
5ANDA089987BUTAPAPMIKART INC1992-10-26ANDA089987_001
6ANDA089988BUTAPAPTrueMIKART INC1992-10-26ANDA089988_001
7ANDA090956BUTALBITAL AND ACETAMINOPHENNEXGEN PHARMA INC2011-08-23ANDA090956_001
8ANDA205120BUTALBITAL AND ACETAMINOPHENTEDOR PHARMA INC2015-10-30ANDA205120_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA087550_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1984-10-19BUTALBITAL AND ACETAMINOPHEN
2ANDA087811_001discontinuedBUTALBITAL (50MG), ACETAMINOPHEN (325MG)ORALTABLETFalse1985-06-19PHRENILIN
3ANDA088944_001discontinuedBUTALBITAL (50MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1985-10-17SEDAPAP
4ANDA089568_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALTABLETFalse1988-10-05BUTALBITAL AND ACETAMINOPHEN
5ANDA089987_001RXACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALTABLETTrueAA1992-10-26BUTAPAP
6ANDA089988_001discontinuedACETAMINOPHEN (650MG), BUTALBITAL (50MG)ORALTABLETFalse1992-10-26BUTAPAP
7ANDA090956_001RXACETAMINOPHEN (300MG), BUTALBITAL (50MG)ORALTABLETTrue2011-08-23BUTALBITAL AND ACETAMINOPHEN
8ANDA205120_001RXACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALTABLETFalseAA2015-10-30BUTALBITAL AND ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12cddfd28-6ce7-4708-8f11-6d4dc33fae5b (view SPL)Butalbital and Acetaminophen TabletsprescriptionHuman PrescriptionSolubiomixlabel2015-10-222694990302
230e483da-eaf1-4c73-9fed-333337f9ba86 (view SPL)Butalbital and Acetaminophen Tablets 50 mg/300 mgprescriptionHuman PrescriptionEcr PharmaceuticalsMANUFACTURE2014-08-257000953000
34e4a9925-67aa-4be7-8bb7-c8b058ffe223 (view SPL)prescriptionHuman PrescriptionInternational Ethical Labs, Inc.2013-11-071115840030
4669e3bd0-fbd9-423c-8654-a78fe650e3e2 (view SPL)Butalbital and Acetaminophen Tablets50 mg/300 mgprescriptionHuman PrescriptionNexgen Pharma, Inc.2013-08-304007227075
585c7db7a-a99a-43ef-9337-9916762ca087 (view SPL)prescriptionHuman PrescriptionMarnel Pharmaceuticals, Inc.2015-01-211006821400
6a81c62d2-8151-42db-bda7-e08578ac5089 (view SPL)PHRENILIN (Butalbital 50 mg and Acetaminophen 325 mg Tablet)prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-12-2311001870842, 001870844Acetaminophen / butalbital Oral Capsule
7be1b8109-725e-4427-9cd9-b468a71a48bd (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-03-061425490495
8ca8a0862-1956-43ad-844d-77153aa09dfb (view SPL)prescriptionHuman PrescriptionMikart, Inc.2013-11-053466720099
9e619b656-4123-4878-b601-b0edad3c428b (view SPL)prescriptionHuman PrescriptionQualitest Pharmaceuticals2015-01-212006032540

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