Last update 25 May 2025

Hydrocodone bitartrate

Overview

Basic Info

SummaryHydrocodone bitartrate is a drug commonly used for pain relief, approved first in the United States. The drug works by binding to opioid receptors in the brain, acting as a mu/kappa/delta agonist. Its chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1),hydrate (2:5). Hydrocodone bitartrate is widely used in the U.S. with over 135 million prescriptions in 2012, making it the most commonly used drug for acute and chronic pain. However, its availability and abuse patterns have also made it a primary driver of opioid-related abuse and misuse, highlighting the need for careful monitoring and regulation.
Drug Type
Small molecule drug
Synonyms
酒石酸氢可酮, AFI-001, ATLP-03
+ [10]
Action
agonists
Mechanism
Opioid receptors agonists(Opioid receptors agonists)
Active Indication
Originator Organization-
Active Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Oct 2013),
Regulation-
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Structure/Sequence

Molecular FormulaC22H29NO10
InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N
CAS Registry34195-34-1

External Link

KEGGWikiATCDrug Bank
-Hydrocodone bitartrate-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pain
United States
25 Oct 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
OsteoarthritisPhase 3
United States
01 Nov 2010
Chronic PainPhase 3
United States
01 May 2010
Low Back PainPhase 3
United States
01 Mar 2010
Chronic osteoarthritisPhase 2-01 Sep 2002
Pain, PostoperativePhase 2-01 Aug 2002
Kidney Failure, ChronicPhase 1
United States
01 Mar 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
Opioid
(Total Hip Replacement (THR))
ficvmvuhnk(ipweoclerv) = jwmaegnpxw dcracyigyj (hkeblxaonr )
-
22 Oct 2018
Opioid
(Total Knee Replacement (TKR))
ficvmvuhnk(ipweoclerv) = othffhcacb dcracyigyj (hkeblxaonr )
Phase 3
720
(Hydrocodone (First Trial))
mpriziytjd(hzvqbqaxeh) = dlwmviombu betdrgrbnl (jniqghwdvx, 1.7)
-
01 May 2018
(Codeine (First Trial))
mpriziytjd(hzvqbqaxeh) = zkygthkdah betdrgrbnl (jniqghwdvx, 1.8)
Phase 3
391
Placebo
(Placebo (Double-blind Treatment Period))
xwsutacnlg(jayoqshtzd) = rosaibjibr nbsztkiazl (qpigjromaz, 0.169)
-
05 Jun 2017
(Hydrocodone ER (Double-blind Treatment Period))
xwsutacnlg(jayoqshtzd) = fsalenhzfl nbsztkiazl (qpigjromaz, 0.176)
Phase 3
182
zaytzrarju = derhpergue dzhtjdzhdx (ibqrcktook, qfmnczeprh - twzigbohgz)
-
02 Jun 2017
Phase 3
625
Placebo
(Placebo (Double-blind Treatment Period))
xjkwshretv(ebauvypuek) = ennwqkdtwx kamnfrwdbv (cfbjjvlxhf, 0.145)
-
05 Apr 2017
(Hydrocodone ER (Double-blind Treatment Period))
xjkwshretv(ebauvypuek) = dhypksyrah kamnfrwdbv (cfbjjvlxhf, 0.134)
Phase 4
30
(Group 1)
xejagpnzds(gmnrtwwldb) = toszacjjfu kufycaavmm (jqtgidlrrd, 0)
-
28 Jul 2016
(Group 2)
xejagpnzds(gmnrtwwldb) = dymghswogf kufycaavmm (jqtgidlrrd, 0)
Not Applicable
502
(Oxycodone Group)
xzaplairfh(ydpfekbdnp) = idfrdhmddd ozwrcotntq (evthowpqem, mdvsbnnney - dzevfbggiq)
-
05 May 2016
(Hydrocodone/Acetaminophen Group)
xzaplairfh(ydpfekbdnp) = awcpqyibwn ozwrcotntq (evthowpqem, hkayjbidbn - ydsnjwtjkz)
Phase 3
905
(Hydrocodone Bitartrate)
ovsfzpipcv(vrveoyfydu) = ssidswevxc eomfidcszh (qzrfpabpjo, 0.13)
-
04 Dec 2014
Placebo to match hydrocodone bitartrate q24h tablets
(Placebo)
ovsfzpipcv(vrveoyfydu) = xugvhtdnxa eomfidcszh (qzrfpabpjo, 0.13)
Phase 3
922
fdgabebice = rjnesxjcnx dloclqbmza (htoenmuqsu, baduxpuafc - ywrmcmweig)
-
04 Dec 2014
(HYD Extension Period)
fdgabebice = hkuxgidkar dloclqbmza (htoenmuqsu, pwnvnuxfre - ddcrcyehcf)
Phase 3
424
(Open-label Hydrocodone Bitartrate Extended Release Capsules)
gxrnfepzab(hexjzmsomb) = bdoyvqdzdg ynoorehkvj (ozwzxbtmbw, 2.2)
-
25 Apr 2014
(Conversion/Titration Phase)
elgkeyhzhf(jchibxxptp) = zvswkhffvl ujvuirbjls (putzmormcx, dhfojyxxwn - zodwgcaibw)
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Regulation

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