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FDA Orange Book · active-ingredient family

Acetaminophen; hydrocodone bitartrate

Acetaminophen; hydrocodone bitartrate is approved in 150 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

150

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (150)

ProductApplicantApplicationTEApproved
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2TRIS PHARMA INCANDA 201295—Dec 30, 2021
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3PRINSTON INCANDA 214928—Dec 30, 2021
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3SANALUZANDA 211690—Feb 07, 2020
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3GRANULESANDA 211729AAJan 03, 2020
HYDROCODONE BITARTRATE AND ACETAMINOPHENWES PHARMA INCANDA 211023AAMar 08, 2019
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4ELITE LABS INCANDA 209924AANov 16, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3ALVOGENANDA 208540—Nov 08, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4ASCENT PHARMS INCANDA 211487AANov 07, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3HIBROW HLTHCAREANDA 207509AAOct 29, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4ALVOGENANDA 209958—Oct 24, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3AUROLIFE PHARMA LLCANDA 207709AASep 13, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3EPIC PHARMA LLCANDA 203863AAMar 30, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3RHODES PHARMSANDA 207808—Mar 30, 2018
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3WES PHARMA INCANDA 210211AAOct 30, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 206869—Jun 23, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3LANNETT CO INCANDA 207172AAJun 22, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3ABHAI LLCANDA 209036AAJun 21, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3ABHAI LLCANDA 209037AAJun 21, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3LANNETT CO INCANDA 207171AAJun 20, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3SPECGX LLCANDA 206718AAMar 31, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3UPSHER SMITH LABSANDA 206484—Mar 24, 2017
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3NOVEL LABS INCANDA 206245—Dec 01, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMSANDA 207137—Nov 29, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3NOVEL LABS INCANDA 206142—Nov 14, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3STRIDES PHARMA INTLANDA 205001—Jul 05, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3STRIDES PHARMA INTLANDA 202935AAJun 15, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3ACTAVIS LABS FL INCANDA 206470—Jun 02, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2AMNEAL PHARMS NYANDA 040746AAMay 10, 2016
ZYFRELCYPRESS PHARM INCANDA 090468—Apr 14, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3RHODES PHARMSANDA 202991AAApr 12, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×6TRIS PHARMA INCANDA 202214AAMar 15, 2016
HYDROCODONE BITARTRATE AND ACETAMINOPHENPHARM ASSOCANDA 040838AAMay 10, 2013
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3AUROLIFE PHARMA LLCANDA 201013AAApr 11, 2012
HYDROCODONE BITARTRATE AND ACETAMINOPHENGENUSANDA 200343—Jan 25, 2012
HYDROCODONE BITARTRATE AND ACETAMINOPHENGENUSANDA 040894AAJul 19, 2011
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3PH HEALTHANDA 090415—Jan 24, 2011
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 040846—Jun 09, 2010
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 040849—Jun 09, 2010
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 040881—Feb 25, 2010
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3CARACOANDA 090265—Dec 23, 2008
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4CARACOANDA 090380—Dec 23, 2008
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3SUN PHARM INDS INCANDA 090118—Dec 23, 2008
HYDROCODONE BITARTRATE AND ACETAMINOPHENPHARM ASSOCANDA 040834—Apr 18, 2008
HYDROCODONE BITARTRATE AND ACETAMINOPHENRANBAXYANDA 040825—Aug 16, 2007
HYDROCODONE BITARTRATE AND ACETAMINOPHENRANBAXYANDA 040824—Aug 16, 2007
HYDROCODONE BITARTRATE AND ACETAMINOPHENRANBAXY LABS LTDANDA 040822—Aug 16, 2007
HYDROCODONE BITARTRATE AND ACETAMINOPHENSUN PHARM INDS LTDANDA 040826—Aug 16, 2007
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040813—Feb 23, 2007
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040769—Aug 28, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040736AAAug 25, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040729—Aug 25, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040748—Aug 25, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040754—Aug 25, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMS NYANDA 040757—Aug 25, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3CHARTWELLANDA 040658—Jan 19, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENSTRIDES PHARMA INTLANDA 040655—Jan 19, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENSTRIDES PHARMA INTLANDA 040656—Jan 19, 2006
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040520—Oct 30, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENCHARTWELLANDA 040482—Sep 25, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODT INCANDA 040508—Aug 29, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABS FLORIDAANDA 040493—May 28, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABS FLORIDAANDA 040495—May 28, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABS FLORIDAANDA 040494—May 28, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040490—May 21, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENCHARTWELLANDA 040432—Jan 22, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040474—Jan 02, 2003
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040478—Nov 08, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040477—Nov 06, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040473—Nov 06, 2002
ANEXSIAMALLINCKRODTANDA 040468—Oct 31, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040469—Oct 25, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2ABLEANDA 040464—Oct 23, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENABLEANDA 040476—Oct 23, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENNESHER PHARMSANDA 040366—Jan 23, 2002
HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODTANDA 040418—Jun 27, 2001
ANEXSIA 5/325SPECGX LLCANDA 040409AAOct 20, 2000
ANEXSIA 7.5/325SPECGX LLCANDA 040405AASep 08, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4BARRANDA 040307—Jul 26, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2BARRANDA 040308—Jul 26, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHENBARRANDA 040309—Jul 26, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHENSPECGX LLCANDA 040400AAJul 26, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHENSTRIDES PHARMA INTLANDA 040355—May 31, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040356—May 31, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040358—May 31, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2CHARTWELLANDA 040248—Apr 28, 2000
ZYDONE×3VINTAGE PHARMS LLCANDA 040288—Nov 27, 1998
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2VINTAGE PHARMS LLCANDA 040281—Sep 30, 1998
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×3VINTAGE PHARMS LLCANDA 040280—Sep 30, 1998
HYDROCODONE BITARTRATE AND ACETAMINOPHENPHARM ASSOCANDA 040182—Mar 13, 1998
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2MALLINCKRODTANDA 040201—Feb 27, 1998
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2MUTUAL PHARMANDA 040240—Nov 26, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2MUTUAL PHARMANDA 040236—Sep 25, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHENUCB INCANDA 040210—Aug 13, 1997
NORCOAPILANDA 040099—Jun 25, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2VINTAGE PHARMSANDA 040144—Apr 25, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040155—Apr 14, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×5APILANDA 040148—Feb 14, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2SANDOZANDA 040149—Jan 27, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHENUCB INCANDA 040134—Nov 21, 1996
VICODIN HPABBVIEANDA 040117—Sep 23, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040157—Apr 12, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4WATSON LABSANDA 040123—Mar 04, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×2WATSON LABSANDA 040122—Mar 04, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 040143—Feb 22, 1996
LORTABUCB INCANDA 040100—Jan 26, 1996
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4WATSON LABSANDA 040094—Sep 29, 1995
HYDROCODONE BITARTRATE AND ACETAMINOPHEN×4MALLINCKRODTANDA 040084—Jun 01, 1995
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081226—Oct 27, 1992
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081051—Aug 28, 1992
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081223—May 29, 1992
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089557—Apr 29, 1992
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089697—Jan 28, 1992
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABSANDA 081079—Aug 30, 1991
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABSANDA 081080—Aug 30, 1991
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABSANDA 081083—Aug 30, 1991
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081067—Nov 30, 1989
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081068—Nov 30, 1989
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081069—Nov 30, 1989
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 081070—Nov 30, 1989
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089698—Aug 25, 1989
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089699—Aug 25, 1989
ALLAYIVAX PHARMSANDA 089907—Jan 13, 1989
VICODIN ESABBVIEANDA 089736—Dec 09, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 089971—Dec 02, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHENWATSON LABSANDA 089883—Dec 01, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMSANDA 089831—Sep 07, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089689—Jun 29, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHENIVAX PHARMSANDA 089696—Apr 21, 1988
CO-GESICCENT PHARMSANDA 089360—Mar 02, 1988
ANEXSIA 7.5/650MALLINCKRODTANDA 089725—Sep 30, 1987
HYDROCODONE BITARTRATE AND ACETAMINOPHENHALSEYANDA 089554—Jun 12, 1987
HYDROCODONE BITARTRATE AND ACETAMINOPHENUSL PHARMAANDA 089290—May 29, 1987
HYDROCODONE BITARTRATE AND ACETAMINOPHENUSL PHARMAANDA 089291—May 29, 1987
ANEXSIAMALLINCKRODTANDA 089160—Apr 23, 1987
TYCOLETORTHO MCNEIL PHARMANDA 089385—Aug 27, 1986
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089271—Jul 16, 1986
NORCETABANAANDA 088871—May 15, 1986
HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKARTANDA 089008—Feb 21, 1986
HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODTANDA 089006—Aug 09, 1985
HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODTANDA 088956—Jul 19, 1985
ACETAMINOPHEN AND HYDROCODONE BITARTRATECENT PHARMSANDA 088898—Mar 27, 1985
HYDROCODONE BITARTRATE AND ACETAMINOPHENBARRANDA 088577—Dec 21, 1984
BANCAP HCFOREST PHARMSANDA 087961—Mar 17, 1983
DURADYNE DHCFOREST PHARMSANDA 087809—Mar 17, 1983
VICODINABBVIEANDA 088058—Jan 07, 1983
LORTABUCB INCANDA 087722—Jul 09, 1982
LORCET-HDMALLINCKRODTANDA 087336—Jul 08, 1982
CO-GESICUCB INCANDA 087757—May 03, 1982
HY-PHENASCHERANDA 087677—May 03, 1982
VICODINABBOTTANDA 085667—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Acetaminophen; hydrocodone bitartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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