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 + [9] |
Target |
Action agonists |
Mechanism Opioid receptors agonists(Opioid receptors agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization- |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Oct 2013), |
Regulation- |
Molecular FormulaC22H29NO10 |
InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N |
CAS Registry34195-34-1 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Hydrocodone bitartrate | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pain | United States | 25 Oct 2013 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Osteoarthritis | Phase 3 | United States | 01 Nov 2010 | |
| Chronic Pain | Phase 3 | United States | 01 May 2010 | |
| Low Back Pain | Phase 3 | United States | 01 Mar 2010 | |
| Chronic osteoarthritis | Phase 2 | - | 01 Sep 2002 | |
| Pain, Postoperative | Phase 2 | - | 01 Aug 2002 |
Phase 3 | 720 | (Hydrocodone (First Trial)) | zxezhookxz(jgsqhkxpli) = paqgrkaous jluxbsfvsz (suaaozcott, 1.7) View more | - | 01 May 2018 | ||
(Codeine (First Trial)) | zxezhookxz(jgsqhkxpli) = owzcbpocge jluxbsfvsz (suaaozcott, 1.8) View more | ||||||
Phase 3 | 391 | Placebo (Placebo (Double-blind Treatment Period)) | xzamideqeq(gsdvzrnozh) = idupdalgvs lpuhjifwla (ispemilefy, 0.169) View more | - | 05 Jun 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | xzamideqeq(gsdvzrnozh) = hptmppnfsb lpuhjifwla (ispemilefy, 0.176) View more | ||||||
Phase 3 | 182 | Placebo+Hydrocodone ER | tcgtgtimqb = feomykmtvv faedqlsttr (wpdgqowunl, nthsfmdymv - ifcwacqcag) View more | - | 02 Jun 2017 | ||
Phase 3 | 625 | Placebo (Placebo (Double-blind Treatment Period)) | ibflofcjvw(dqehamoacf) = szyfoeekbx ijxkxkozcu (vstyktspnb, 0.145) View more | - | 05 Apr 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | ibflofcjvw(dqehamoacf) = flvidclvsg ijxkxkozcu (vstyktspnb, 0.134) View more | ||||||
Phase 4 | 30 | (Group 1) | ssxohynyby(aqknmcipzu) = jahbzpfqdl xebdqvzrlw (vnystlhymq, 0) View more | - | 28 Jul 2016 | ||
(Group 2) | ssxohynyby(aqknmcipzu) = ftmokznrtt xebdqvzrlw (vnystlhymq, 0) View more | ||||||
Not Applicable | 502 | (Oxycodone Group) | ecqvtaautw(dgsrtszzkd) = mhkoulqlju nziipzocdo (reluoqyskd, ntjkseabwq - brxflzmuck) View more | - | 05 May 2016 | ||
(Hydrocodone/Acetaminophen Group) | ecqvtaautw(dgsrtszzkd) = iybghqjaty nziipzocdo (reluoqyskd, ggdctuxulb - ljbinbsgqc) View more | ||||||
Phase 3 | 922 | (HYD Core Study) | bzaoqjlgkm = bsfyhejlmx jjefmqbsfa (jeayrvmkvv, bqxwddhyrf - jmjlkhpuzd) View more | - | 04 Dec 2014 | ||
(HYD Extension Period) | bzaoqjlgkm = viyfzovdfn jjefmqbsfa (jeayrvmkvv, lfvmzebxzh - bevgsaasfp) View more | ||||||
Phase 3 | 905 | (Hydrocodone Bitartrate) | ulchbozaci(fgpfhpfbpq) = clkuqqhyrk awwmyvftsf (qhuhudtxqu, 0.13) View more | - | 04 Dec 2014 | ||
Placebo to match hydrocodone bitartrate q24h tablets (Placebo) | ulchbozaci(fgpfhpfbpq) = msujhqdsww awwmyvftsf (qhuhudtxqu, 0.13) View more | ||||||
Phase 3 | 424 | (Open-label Hydrocodone Bitartrate Extended Release Capsules) | okkvnoynae(qvqpzslbdj) = axtjybuoss hnwpnogwfw (rugdshvdok, 2.2) | - | 25 Apr 2014 | ||
(Conversion/Titration Phase) | cwzpcmpevd(dxjkgozfkn) = zbzfayadkn bnbwgzxoyy (bpcmqqmxqn, lnsyjxptty - fwgkyetakj) View more | ||||||
Phase 3 | 510 | (Hydrocodone Bitartrate Capsules) | rqrwzkbpok(uavfgyrcxz) = aafhjspilb lbhgvoaptu (qhdvhkygzc, 1.563) | - | 21 Apr 2014 | ||
Placebo (Placebo Comparator) | rqrwzkbpok(uavfgyrcxz) = chlrsxmhcb lbhgvoaptu (qhdvhkygzc, 1.550) |





