hydrocodone

Trade name: hycodan

Small moleculeapproved

Approved

Mar 23, 1943

Benzhydrocodone is a prodrug of hydrocodone. Benzhydrocodone is formed by covalently bonding hydrocodone to benzoic acid. Benzhydrocodone itself is not pharmacologically active, but must be metabolized to hydrocodone by enzymes in the intestinal tract to optimally deliver its pharmacologic effects. Hydrocodone is a full agonist of the opioid receptors with a higher affinity for the mu-opioid receptor. Upon binding, hydrocodone produces an analgesic effect with no ceiling. APADAZ a combination of benzhydrocodone and acetaminophen is FDA approved and indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. APADAZ, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death. — NCATS

Clinical trial activity

144 trials · 100 clinical orgs · 84 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Feb 1, 2002 (NCT00390260)

Timeline

1940s

Mar 23, 1943
Knoll — Earliest FDA Approval
Mar 23, 1943
Genus Oncology, LLC — Marketing Organization
Mar 23, 1943
Genus Oncology, LLC — NDA Secondary Org
Mar 23, 1943
Knoll — NDA Organization

1980s

May 3, 1982
Ascher — Marketing Organization
May 3, 1982
UCB — Marketing Organization
Jul 8, 1982
Mallinckrodt — Marketing Organization
Jul 8, 1982
Avon Products — Marketing Organization
Jan 7, 1983
AbbVie — Marketing Organization
Mar 3, 1983
Wockhardt — Marketing Organization
Mar 17, 1983
Forest Laboratories — Marketing Organization
Dec 14, 1983
Abbott — Marketing Organization
Mar 27, 1985
Century Pharmaceuticals — Marketing Organization
Jul 30, 1985
King Pharmaceuticals — Marketing Organization
May 15, 1986
Abana — Marketing Organization
Aug 27, 1986
Johnson and Johnson — Marketing Organization
Apr 23, 1987
International Minerals and Chemical Corporation — Marketing Organization
Dec 31, 1987
UCB — NDA Secondary Org
Jan 25, 1988
Schwarz Pharma — Marketing Organization
Apr 21, 1988
Ivax — Marketing Organization
Sep 7, 1988
Vintage — Marketing Organization
Dec 1, 1988
Watson Pharmaceuticals — Marketing Organization

1990s

Jan 27, 1997
Sandoz — Marketing Organization
Jan 27, 1997
Novartis — Marketing Organization
Feb 14, 1997
Allergan — Marketing Organization
Feb 14, 1997
SmithKline Beecham — Marketing Organization
Sep 23, 1997
AbbVie — NDA Secondary Org
Sep 25, 1997
Mutual Pharmaceutical — Marketing Organization
Mar 13, 1998
Pharmaceutical Associates — Marketing Organization

2000s

Apr 28, 2000
Chartwell Pharmaceuticals — Marketing Organization
May 31, 2000
Strides Pharma Science — Marketing Organization
Jul 26, 2000
Barr Laboratories — Marketing Organization
Jul 26, 2000
Specgx Llc — Marketing Organization
Sep 29, 2000
Alpharma — Marketing Organization
Dec 1, 2000
Actavis — Marketing Organization
Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
Jan 23, 2002
Nesher Pharms — Marketing Organization
Oct 23, 2002
Able Laboratories — Marketing Organization
Jan 22, 2003
ANDA Repository — Marketing Organization
Apr 11, 2003
Teva — Marketing Organization
Aug 16, 2007
Ranbaxy — Marketing Organization
Sep 24, 2007
ECR Pharmaceuticals — Marketing Organization
Feb 8, 2008
Akorn, Inc. — Marketing Organization
Feb 8, 2008
Hi Tech Pharmaceuticals — Marketing Organization
Dec 23, 2008
Caraco Pharmaceutical Laboratories — Marketing Organization
Dec 23, 2008
Sun Pharmaceuticals — Marketing Organization

2010s

Jun 23, 2010
Ani Pharmaceuticals — Marketing Organization
Jan 24, 2011
Apax Partners — Marketing Organization
Apr 20, 2011
Novel Anti-Infective Technologies, LLC — Marketing Organization
Jun 8, 2011
Cypress Pharmaceutical — Marketing Organization
Jun 8, 2011
Currax Pharmaceuticals — NDA Secondary Org
Jan 25, 2012
VistaPharm, Inc. — Marketing Organization
Apr 11, 2012
Aurobindo Pharma — Marketing Organization
Jun 29, 2012
Neos Therapeutics, Inc — Marketing Organization
Jun 29, 2012
AYTU BioScience — Marketing Organization
Mar 27, 2013
Tris Pharma, Inc. — Marketing Organization
Oct 25, 2013
Pernix — NDA Secondary Org
Oct 25, 2013
Recro Pharma, Inc. — Marketing Organization
Oct 25, 2013
Recro Pharma, Inc. — NDA Secondary Org
Apr 29, 2014
Padagis Us — Marketing Organization
Apr 29, 2014
Paddock Laboratories — Marketing Organization
Nov 14, 2014
Sovereign Pharmaceuticals — Marketing Organization
Nov 14, 2014
Sovereign Pharmaceuticals — NDA Secondary Org
Nov 20, 2014
Purdue Pharmaceuticals — NDA Secondary Org
May 14, 2015
Mikart — Marketing Organization
May 14, 2015
Chartwell Pharmaceuticals — NDA Secondary Org
Aug 3, 2015
Mayne Pharma — Marketing Organization
Apr 12, 2016
Rhodes Pharmaceuticals, L.P. — Marketing Organization
Apr 14, 2016
Pernix — Marketing Organization
Jun 2, 2016
Allergan PLC (2015) — Marketing Organization
Jun 15, 2016
Par Pharmaceuticals — Marketing Organization
Nov 29, 2016
Amneal Pharmaceuticals — Marketing Organization
Jan 17, 2017
Teva — NDA Secondary Org
Feb 21, 2017
Abhai LLC — Marketing Organization
Mar 6, 2017
Torrent Pharmaceuticals Limited — Marketing Organization
Mar 24, 2017
Upsher-Smith Laboratories — Marketing Organization
May 25, 2017
Alvogen — Marketing Organization
Jun 9, 2017
Acella Pharmaceuticals — Marketing Organization
Jun 20, 2017
Lannett Company, Inc. — Marketing Organization
Aug 7, 2017
Avanthi Pharma — Marketing Organization
Oct 30, 2017
Wes Pharma Inc — Marketing Organization
Mar 30, 2018
Epic Pharma Llc — Marketing Organization
Apr 25, 2018
Eci Pharmaceuticals Llc — Marketing Organization
Apr 25, 2018
Eci Pharmaceuticals Llc — NDA Secondary Org
Nov 7, 2018
Ascent Pharmahealth — Marketing Organization
Nov 16, 2018
Nostrum Laboratories — Marketing Organization
Nov 16, 2018
Elite Laboratories, Inc — Marketing Organization
Mar 8, 2019
Eywa Pharma — Marketing Organization
Jun 11, 2019
Esteve Labs — Marketing Organization

2020s

Jan 3, 2020
Granules India — Marketing Organization
Feb 7, 2020
Cerovene — Marketing Organization
Feb 7, 2020
Exeltis — Marketing Organization
May 28, 2021
LGM Pharma — Marketing Organization
Dec 30, 2021
Prinston Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Opioid receptors; mu/kappa/deltaAGONIST
Opioid receptors; mu/kappa/delta agonist

Combination products

codamine
with phenylpropanolamine
co-gesic
with acetaminophen
Also known as allay, anexsia, bancap hc, hydrocodone/acetaminophen 5 mg-325 mg oral tablet, hy-phen, lorcet-h, lortab, norcet, norco, tycolet, vicodin, vicodin es, vicodin hp, zydone, zyfrel
hycodan
with homatropine
Also known as tussigon
hycofenix
with guaifenesin, pseudoephedrine
obredon
with guaifenesin
Also known as flowtuss, xtrelus
rezira
with pseudoephedrine
tussionex pennkinetic
with chlorpheniramine
Also known as hydrocodone polistirex and chlorpheniramne polistirex, tussicaps
vicoprin
with acetylsalicylic acid
Also known as azdone
vicoprofen
with ibuprofen
Also known as reprexain
vituz
with dexchlorpheniramine maleate
zutripro
with dexchlorpheniramine maleate, pseudoephedrine

Approval history

approvedMar 23, 1943

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2c3c1O[C@H]1C(=O)CC[C@H]4[C@@H](C2)N(C)CC[C@]314.O.O.O=C(O)C(O)C(O)C(=O)O

Mol. weight: 485.49 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warningProdrug

Sources

Also known as

4,5-alpha-epoxy-3-methoxy-17-methylmorphinan-6-one
4,5-alpha-epoxy-3-methoxy-17-methylmorphinan-6-one
abt-712
abt-712
acetaminophen - hydrocodone
acetaminophen, hydrocodone drug combination
acetaminophen, hydrocodone tartrate drug combination
dicodid
dicodid
dihydrocodeinone
dihydrocodeinone
dihydrocodeinone
(-)-dihydrocodeinone
(-)-dihydrocodeinone
dihydrocodeinone bitartrate
dihydrocodeinone bitartrate
hidrocodona
hidrocodona
hycodan
hycodan
hydrocodon
hydrocodon
hydrocodon
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone
hydrocodone bitartrate
hydrocodone bitartrate
hydrocodone bitartrate
hydrocodone bitartrate
hydrocodone bitartrate
hydrocodone polistirex
hydrocodone polistirex
hydrocodone polistirex
hydrocodone polistirex
hydrocodone polistirex
hydrocodonum
hydrocodonum
hydrocone
hydrocone
hydroconum
hydroconum
hydroxycontin
idrocodone
idrocodone
mercodinone
mercodinone
mnk-155
multacodin
norco
norco
vicodin
vicodin
vicodin
vicodin es
vicodin hp

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07158476	Phase 4	Oct 21, 2025	St. Louis University
NCT07195669	Phase 4	Oct 1, 2025	Louisiana State University
NCT06780202	Phase 2	Jan 27, 2025	Emory University
NCT06619847	Phase 2	Oct 31, 2024	Vertex
NCT06585163	Phase 1	Sep 30, 2024	National Institute on Drug Abuse (NIDA), Quivive Pharma, Inc., The Cleveland Clinic
NCT06232577	Phase 2	Mar 27, 2024	University of Texas at Houston
NCT05897203	Phase 2	Mar 3, 2023	Makerere University, Medical Research Council-UVRI Uganda Research Unit on AIDS
NCT05640674	Phase 4	Dec 31, 2022	Baylor University
NCT05544734	Phase 4	Nov 10, 2022	Cornell University
NCT05558410	Phase 3	Oct 10, 2022	Vertex
NCT05553366	Phase 3	Oct 3, 2022	Vertex
NCT05265052	Phase 2	Sep 30, 2022	3D Medicines, Henan Medical University
NCT05572190	Phase 1	Sep 27, 2022	Elysium Therapeutics, Inc., Medpace, Inc., National Institute on Drug Abuse (NIDA)
NCT04939987	Phase 2/Phase 3 (Phase 3)	Jan 31, 2022	Wake Forest University
NCT05160272	Phase 2	Dec 31, 2021	komIT - Center of Competence for Innovative Diabetes Therapy, The Deutsche Diabetes Forschungsgesellschaft e.V.
NCT05034952	Phase 2	Aug 30, 2021	Vertex
NCT04977336	Phase 2	Jul 19, 2021	Vertex
NCT04976387	Phase 3	Jul 2, 2021	Loma Linda University
NCT04905563	Phase 4	Jun 7, 2021	The Campbell Foundation, University of Tennessee
NCT04429919	Phase 2	Jun 30, 2020	Algiax Pharmaceuticals GmbH, FGK Clinical Research GmbH, University of Applied Sciences Würzburg-Schweinfurt

Showing 20 of 144 trials

Page 1 / 8

Organizations

Research & Development (100)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Abbott	For profit	8	8	3	2003
Mallinckrodt	For profit	8	7	2	2003
Zogenix, Inc.	For profit	8	8	3	2002
Teva	For profit	7	7	2	2010
AbbVie	For profit	6	6	2	2008
Vertex	For profit	6	6	2	2017
Cephalon	For profit	5	3	2	2010
Charleston Laboratories, Inc	For profit	5	5	2	2013
Henry Ford Health System	Academic/Hospital	4	4	3	2019
Loma Linda University	Academic/Hospital	4	4	3	2015
Purdue Pharmaceuticals	For profit	4	4	3	2011
SPARC	For profit	4	4	1	2015
University of Texas at Houston	Academic/Hospital	3	3	2	2017
Yeshiva University	Academic/Hospital	3	3	2	2012
Albany Medical College	Academic/Hospital	2	2	1	2007
Bayer	For profit	2	1	2	2014
Baylor University	Academic/Hospital	2	2	2	2009
Department of Veteran Affairs	Government	2	2	2	2007
Emory University	Academic/Hospital	2	2	2	2014
Grunenthal	For profit	2	2	1	2017

100 organizations

Page 1 / 5

Marketing (112)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jan 22, 2003
AYTU BioScience	For profit	MKTG	Jun 29, 2012
Abana	For profit	MKTG	May 15, 1986
AbbVie	For profit	MKTG	Jan 7, 1983
AbbVie	For profit	NDA2	Sep 23, 1997
Abbott	For profit	MKTG	Dec 14, 1983
Abhai LLC	For profit	MKTG	Feb 21, 2017
Able Laboratories	For profit	MKTG	Oct 23, 2002
Acella Pharmaceuticals	For profit	SYN	Jun 9, 2017
Acella Pharmaceuticals	For profit	MKTG	Jun 9, 2017
Actavis	For profit	MKTG	Dec 1, 2000
Actavis	For profit	SYN	Dec 31, 2003
Actavis	For profit	SYN	Jul 5, 1983
Akorn, Inc.	For profit	MKTG	Feb 8, 2008
Allergan	For profit	MKTG	Feb 14, 1997
Allergan PLC (2015)	For profit	MKTG	Jun 2, 2016
Alpharma	For profit	MKTG	Sep 29, 2000
Alvogen	For profit	SYN	Jan 21, 2020
Alvogen	For profit	SYN	Oct 24, 2018
Alvogen	For profit	MKTG	May 25, 2017
Amneal Pharmaceuticals	For profit	MKTG	Nov 29, 2016
Amneal Pharmaceuticals	For profit	SYN	Mar 18, 2004
Ani Pharmaceuticals	For profit	MKTG	Jun 23, 2010
Ani Pharmaceuticals	For profit	SYN	Jun 23, 2010
Apax Partners	For profit	MKTG	Jan 24, 2011
Ascent Pharmahealth	For profit	MKTG	Nov 7, 2018
Ascher	For profit	MKTG	May 3, 1982
Aurobindo Pharma	For profit	MKTG	Apr 11, 2012
Avanthi Pharma	For profit	MKTG	Aug 7, 2017
Avon Products	For profit	MKTG	Jul 8, 1982
Barr Laboratories	For profit	MKTG	Jul 26, 2000
Caraco Pharmaceutical Laboratories	For profit	MKTG	Dec 23, 2008
Century Pharmaceuticals	For profit	MKTG	Mar 27, 1985
Cerovene	For profit	MKTG	Feb 7, 2020
Chartwell Pharmaceuticals	For profit	MKTG	Apr 28, 2000
Chartwell Pharmaceuticals	For profit	NDA2	May 14, 2015
Currax Pharmaceuticals	For profit	NDA2	Jun 8, 2011
Cypress Pharmaceutical	For profit	MKTG	Jun 8, 2011
Cypress Pharmaceutical	For profit	SYN	Apr 14, 2016
ECR Pharmaceuticals	For profit	MKTG	Sep 24, 2007
Eci Pharmaceuticals Llc	For profit	MKTG	Apr 25, 2018
Eci Pharmaceuticals Llc	For profit	NDA2	Apr 25, 2018
Elite Laboratories, Inc	For profit	MKTG	Nov 16, 2018
Epic Pharma Llc	For profit	MKTG	Mar 30, 2018
Esteve Labs	For profit	MKTG	Jun 11, 2019
Exeltis	For profit	MKTG	Feb 7, 2020
Eywa Pharma	For profit	MKTG	Mar 8, 2019
Forest Laboratories	For profit	MKTG	Mar 17, 1983
Genus Oncology, LLC	For profit	MKTG	Mar 23, 1943
Genus Oncology, LLC	For profit	NDA2	Mar 23, 1943
Granules India	For profit	MKTG	Jan 3, 2020
Granules India	For profit	SYN	Jan 3, 2020
Halsey	For profit	MKTG	—
Hi Tech Pharmaceuticals	For profit	MKTG	Feb 8, 2008
International Minerals and Chemical Corporation	For profit	MKTG	Apr 23, 1987
Ivax	For profit	MKTG	Apr 21, 1988
Johnson and Johnson	For profit	MKTG	Aug 27, 1986
King Pharmaceuticals	For profit	MKTG	Jul 30, 1985
Knoll	For profit	NDA	Mar 23, 1943
LGM Pharma	For profit	MKTG	May 28, 2021
Lannett Company, Inc.	For profit	MKTG	Jun 20, 2017
Mallinckrodt	For profit	MKTG	Jul 8, 1982
Mallinckrodt	For profit	SYN	Aug 29, 2003
Mayne Pharma	For profit	MKTG	Aug 3, 2015
Mikart	For profit	MKTG	May 14, 2015
Mikart	For profit	SYN	Feb 21, 1986
Mutual Pharmaceutical	For profit	MKTG	Sep 25, 1997
Neos Therapeutics, Inc	For profit	MKTG	Jun 29, 2012
Neos Therapeutics, Inc	For profit	SYN	Jun 29, 2012
Nesher Pharms	For profit	MKTG	Jan 23, 2002
Nostrum Laboratories	For profit	MKTG	Nov 16, 2018
Novartis	For profit	MKTG	Jan 27, 1997
Novel Anti-Infective Technologies, LLC	For profit	MKTG	Apr 20, 2011
Padagis Us	For profit	MKTG	Apr 29, 2014
Paddock Laboratories	For profit	SYN	Apr 29, 2014
Paddock Laboratories	For profit	MKTG	Apr 29, 2014
Par Pharmaceuticals	For profit	MKTG	Jun 15, 2016
Pernix	For profit	NDA2	Oct 25, 2013
Pernix	For profit	MKTG	Apr 14, 2016
Pharmaceutical Associates	For profit	MKTG	Mar 13, 1998
Prinston Inc	For profit	MKTG	Dec 30, 2021
Purdue Pharmaceuticals	For profit	NDA2	Nov 20, 2014
Ranbaxy	For profit	MKTG	Aug 16, 2007
Ranbaxy	For profit	SYN	Aug 16, 2007
Recro Pharma, Inc.	For profit	MKTG	Oct 25, 2013
Recro Pharma, Inc.	For profit	NDA2	Oct 25, 2013
Rhodes Pharmaceuticals, L.P.	For profit	MKTG	Apr 12, 2016
Sandoz	For profit	MKTG	Jan 27, 1997
Schwarz Pharma	For profit	MKTG	Jan 25, 1988
SmithKline Beecham	For profit	MKTG	Feb 14, 1997
Sovereign Pharmaceuticals	For profit	MKTG	Nov 14, 2014
Sovereign Pharmaceuticals	For profit	NDA2	Nov 14, 2014
Specgx Llc	For profit	MKTG	Jul 26, 2000
Strides Pharma Science	For profit	MKTG	May 31, 2000
Sun Pharmaceuticals	For profit	MKTG	Dec 23, 2008
Sun Pharmaceuticals	For profit	SYN	Aug 16, 2007
Teva	For profit	SYN	Jul 19, 1999
Teva	For profit	MKTG	Apr 11, 2003
Teva	For profit	SYN	Jan 17, 2017
Teva	For profit	NDA2	Jan 17, 2017
Torrent Pharmaceuticals Limited	For profit	MKTG	Mar 6, 2017
Tris Pharma, Inc.	For profit	MKTG	Mar 27, 2013
UCB	For profit	MKTG	May 3, 1982
UCB	For profit	NDA2	Dec 31, 1987
Upsher-Smith Laboratories	For profit	MKTG	Mar 24, 2017
Vintage	For profit	MKTG	Sep 7, 1988
Vintage	For profit	SYN	Sep 30, 1998
VistaPharm, Inc.	For profit	MKTG	Jan 25, 2012
Watson Pharmaceuticals	For profit	MKTG	Dec 1, 1988
Watson Pharmaceuticals	For profit	SYN	May 28, 2003
Wes Pharma Inc	For profit	MKTG	Oct 30, 2017
Wockhardt	For profit	MKTG	Mar 3, 1983