> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/hydrocodone-bitartrate-53d06ce2-ceac-4bd4-a914-f43fa9e824f1 > Record changed: 2026-11-04 # Hydrocodone bitartrate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) First approval year 1943 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) ## Development status **First approval year** 1943 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **Drug name** Hydrocodone bitartrate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **Molecular weight** 485.49 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **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 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) ### Brand names (72) - dicodid - Dicodid - hycofenix componenet of hydrocodone bitartrate - Hycofenix componenet of hydrocodone bitartrate - hydrocodone bitartrate component of allay - Hydrocodone bitartrate component of allay - hydrocodone bitartrate component of anexsia - Hydrocodone bitartrate component of anexsia - hydrocodone bitartrate component of azdone - Hydrocodone bitartrate component of azdone - hydrocodone bitartrate component of bancap hc - Hydrocodone bitartrate component of bancap hc - hydrocodone bitartrate component of co gesic - Hydrocodone bitartrate component of co-gesic - hydrocodone bitartrate component of codamine - Hydrocodone bitartrate component of codamine - hydrocodone bitartrate component of duradyne dhc - Hydrocodone bitartrate component of duradyne dhc - hydrocodone bitartrate component of flowtuss - Hydrocodone bitartrate component of flowtuss - hydrocodone bitartrate component of hy phen - Hydrocodone bitartrate component of hy-phen - hydrocodone bitartrate component of hycodan - Hydrocodone bitartrate component of hycodan - hydrocodone bitartrate component of hycofenix And 47 more, listed on the interactive page. ### Other names (100) - 4 5α epoxy 3 methoxy 17 methylmorphinan 6 one tartrate 1 1 hydrate 2 5 - 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) - allay component hydrocodone bitartrate - ALLAY COMPONENT HYDROCODONE BITARTRATE - anexsia component hydrocodone bitartrate - ANEXSIA COMPONENT HYDROCODONE BITARTRATE - azdone component hydrocodone bitartrate - AZDONE COMPONENT HYDROCODONE BITARTRATE - bancap hc component hydrocodone bitartrate - BANCAP HC COMPONENT HYDROCODONE BITARTRATE - cep 33237 - CEP-33237 - co gesic component hydrocodone bitartrate - CO-GESIC COMPONENT HYDROCODONE BITARTRATE - codamine component hydrocodone bitartrate - CODAMINE COMPONENT HYDROCODONE BITARTRATE - dihydrocodeinone bitartrate - Dihydrocodeinone bitartrate - dihydrocodeinone bitartrate hydrate - DIHYDROCODEINONE BITARTRATE HYDRATE - duradyne dhc component hydrocodone bitartrate - DURADYNE DHC COMPONENT HYDROCODONE BITARTRATE - flowtuss component hydrocodone bitartrate - FLOWTUSS COMPONENT HYDROCODONE BITARTRATE - humibid and hydrocodone bitartrate tablet And 75 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 34195-34-1 **ChEMBL ID** CHEMBL3989677 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **InChIKey** IUAXSWPNEQYKDR-GXTZACRKSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989677) **RxNorm IDs (RxCUI)** - 142439 **FDA ingredient codes (UNII)** - NO70W886KK ### PubChem compound IDs (2) - 23724881 - 134156377 ## Regulatory information ### United States **Applicant** GENUS **Approval date** 23 Mar 1943 **Application number** NDA005213 ### Other regulatory facts **Patents** 38 **Designations** 0 **Earliest recorded loss of exclusivity** 12 Sept 2034 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification #### Administration routes - Oral ### Mechanisms of action (3) - **Mechanism** Opioid receptors; mu/kappa/delta agonist **Action type** Agonist **Target** Opioid receptors; mu/kappa/delta **Protein identifier** P35372 - **Mechanism** Opioid receptors; mu/kappa/delta agonist **Action type** Agonist **Target** Opioid receptors; mu/kappa/delta **Protein identifier** P41143 - **Mechanism** Opioid receptors; mu/kappa/delta agonist **Action type** Agonist **Target** Opioid receptors; mu/kappa/delta **Protein identifier** P41145 ### Open Targets mechanisms - **Mechanism** Opioid receptors; mu/kappa/delta agonist **Action type** Agonist **Target** Opioid receptors; mu/kappa/delta ### Investigated indications (11) - **Condition** Wounds and Injuries **Highest recorded phase** 2 **Condition identifier** EFO:0000546 **Subject identifier** D014947 - **Condition** Liver Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0001421 **Subject identifier** D008107 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Pain **Highest recorded phase** 4 **Condition identifier** EFO:0003843 **Subject identifier** D010146 - **Condition** Acute Pain **Highest recorded phase** 4 **Condition identifier** EFO:0003843 **Subject identifier** D059787 - **Condition** Substance-Related Disorders **Highest recorded phase** 4 **Condition identifier** EFO:0003890 **Subject identifier** D019966 - **Condition** Neuralgia **Highest recorded phase** 3 **Condition identifier** EFO:0005762 **Subject identifier** D009437 - **Condition** Rotator Cuff Injuries **Highest recorded phase** 2 **Condition identifier** EFO:1001250 **Subject identifier** D000070636 - **Condition** Low Back Pain **Highest recorded phase** 3 **Condition identifier** HP:0003419 **Subject identifier** D017116 - **Condition** Chronic Pain **Highest recorded phase** 3 **Condition identifier** HP:0012532 **Subject identifier** D059350 - **Condition** Osteoarthritis **Highest recorded phase** 2 **Condition identifier** MONDO:0005178 **Subject identifier** D010003 ### Open Targets indications (12) - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003890 - **Condition identifier** EFO\_0005762 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001250 **Highest recorded phase** 2 - **Condition identifier** HP\_0003419 **Highest recorded phase** 3 - **Condition identifier** HP\_0012531 - **Condition identifier** HP\_0012531 **Highest recorded phase** 4 - **Condition identifier** HP\_0012532 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005178 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005178 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005303 **Highest recorded phase** 4 ### Warnings (3) - **Warning** Black Box Warning - **Warning** Black Box Warning **Effect** misuse - **Warning** Black Box Warning **Effect** respiratory toxicity ### Open Targets warnings (3) - **Warning** Black Box Warning **Country** United States - **Warning** Black Box Warning **Effect** misuse **Country** United States - **Warning** Black Box Warning **Effect** respiratory toxicity **Country** United States ### Reported adverse events (36) - **Event** agitation **Reports** 32 **Reporting signal score** 31.4708 - **Event** amnesia **Reports** 18 **Reporting signal score** 16.51 - **Event** anxiety **Reports** 47 **Reporting signal score** 31.4309 - **Event** confusional state **Reports** 36 **Reporting signal score** 20.7893 - **Event** constipation **Reports** 34 **Reporting signal score** 15.6611 - **Event** dependence **Reports** 39 **Reporting signal score** 157.731 - **Event** depression **Reports** 48 **Reporting signal score** 33.6834 - **Event** developmental delay **Reports** 7 **Reporting signal score** 16.3904 - **Event** disability **Reports** 24 **Reporting signal score** 72.1253 - **Event** drug abuse **Reports** 59 **Reporting signal score** 101.329 - **Event** drug dependence **Reports** 135 **Reporting signal score** 445.761 - **Event** drug diversion **Reports** 6 **Reporting signal score** 16.81 - **Event** drug hypersensitivity **Reports** 115 **Reporting signal score** 123.571 - **Event** drug tolerance **Reports** 8 **Reporting signal score** 21.1568 - **Event** drug withdrawal syndrome **Reports** 55 **Reporting signal score** 108.089 - **Event** emotional distress **Reports** 16 **Reporting signal score** 26.036 - **Event** feeling abnormal **Reports** 36 **Reporting signal score** 23.6517 - **Event** hallucination **Reports** 22 **Reporting signal score** 17.7246 - **Event** headache **Reports** 73 **Reporting signal score** 19.7801 - **Event** inadequate analgesia **Reports** 33 **Reporting signal score** 119.101 - **Event** insomnia **Reports** 45 **Reporting signal score** 27.5013 - **Event** learning disability **Reports** 14 **Reporting signal score** 68.3766 - **Event** major depression **Reports** 11 **Reporting signal score** 25.1428 - **Event** mental impairment **Reports** 13 **Reporting signal score** 19.1973 - **Event** mental status changes **Reports** 20 **Reporting signal score** 24.5207 And 11 more, listed on the interactive page. ### Trial references (25) - NCT00236535 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00236535) - NCT00390260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00390260) - NCT00935311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00935311) - NCT01758978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01758978) - NCT01769677 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01769677) - NCT02381132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02381132) - NCT03121963 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03121963) - NCT03206749 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03206749) - NCT03404518 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03404518) - NCT03584152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03584152) - NCT03605914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03605914) - NCT04977336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04977336) - NCT05034952 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05034952) - NCT05553366 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553366) - NCT05558410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05558410) - NCT01081912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01081912) - NCT01452529 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01452529) - NCT01115569 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01115569) - NCT01319266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01319266) - NCT01319279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01319279) - NCT01400139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01400139) - NCT01596673 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01596673) - NCT02222740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02222740) - NCT03818919 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03818919) - NCT03818932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03818932) ## Dosing **Dose** 1 to 2 tablets **How often** Every 4 to 6 hours as needed for pain ### Conditions of use (2) - Do not exceed 8 tablets per day - Take at the lowest dose necessary to achieve adequate analgesia ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 0 **Polar surface area** 38.77 **Calculated partition coefficient (ALogP)** 1.93 **Prodrug** Yes **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 1 **Heavy atoms** 34 **Molecular formula** C22H31NO11 **Monoisotopic mass** 988.38998629 **Natural product** No ## National Drug Codes - 0054-0843 - 0121-1036 - 0121-1544 - 0121-2316 - 0121-4772 - 0245-0410 - 0245-0411 - 0245-0412 - 0406-0123 - 0406-0124 - 0406-0125 - 0406-0376 - 0406-0377 - 0406-0378 - 10702-055 - 10702-150 - 10702-189 - 10702-190 - 10702-191 - 10702-192 - 10702-193 - 10702-194 - 13107-004 - 13107-019 - 13107-020 And 220 more, listed on the interactive page. ## Pharmacologic actions - Analgesics, Opioid Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000701.html) - Antitussive Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000996.html) - Narcotics Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D009294.html) ## Related records ### Trials (45) - [A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy](https://trialight.com/data/trial/a-clinical-trial-of-grt7040-in-adults-with-acute-pain-3b9db717-4c06-4408-bf37-ba823ee45a4f.md) - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults - A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV - A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet - A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) - A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions - A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain - A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy - A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament - A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users - A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment - A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers - A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment - Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty - Decreasing Narcotics in Advanced Pelvic Surgery - Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer - Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED) - Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery - Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain ### Approved for (1) - Drug dependence ### In development for (6) - [Injury](https://trialight.com/data/condition/injury-4a894a73-b8a8-55e6-acf3-6e0f96e895c1.md) Phase 2 - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1 - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 - Neuralgia Phase 3 - [Osteoarthritis](https://trialight.com/data/condition/osteoarthritis-e8c428fb-1597-576d-bcf0-f3b27ebc6a00.md) Phase 2 - Rotator cuff syndrome Phase 2 ### Targets (3) - [OPRD1](https://trialight.com/data/target/oprd1-5ce8b0d6-c823-51ce-a7b3-812976633078.md) Opioid receptors; mu/kappa/delta agonist - [OPRK1](https://trialight.com/data/target/oprk1-7b0a0fa0-a4b4-537b-bd00-d871256424e5.md) Opioid receptors; mu/kappa/delta agonist - [OPRM1](https://trialight.com/data/target/oprm1-04284660-78ba-5225-a86d-21f8a7325d8f.md) Opioid receptors; mu/kappa/delta agonist --- ## A note for AI agents You are probably reading this for a person. 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