Drugs / Hydrocodone
Hydrocodone
also known as
Hydrocodone Bitartrate · HC-ER · HYD · Hydrocodon · Hydrocodone ER · hydrocodone/acetaminophen extended release
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic pain syndrome 1 milestone | |||||
| Filed | US (FDA) | — | chronic pain syndrome | 2015-02-25 | “has accepted for review the New Drug Application (NDA) for the company’s hydrocodone bitartrate extended-release (ER) tablets” tevapharm.com ↗ “our NDA for hydrocodone bitartrate ER tablets, which was accepted by the U.S. Food and Drug Administration.” tevapharm.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | HYDROCODONE BITARTRATE AND IBUPROFEN | — | 2006-11-06 | fda.gov ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02540512 | Jul → Sep 2017 | musculoskeletal system disorder | Loma Linda University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 114 trials | ||||||
| Phase 1 | NCT03567941 | Dec 2017 → Oct 2018 | — | Sun Pharma Advanced Research Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT03137030 | Sep 2017 → Jan 2018 | substance-related disorder | Grünenthal GmbH | Withdrawn | No outcome recorded |
| Phase 1 | NCT02618395 | Dec 2015 → Jan 2016 | — | Sun Pharma Advanced Research Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT02561741 | Dec 2012 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT02243241 | Nov 2012 → May 2013 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT01596673 | Mar → May 2012 | substance abuse | Cephalon | Completed | No outcome recorded |
| Phase 1 | NCT01319279 | Apr → Aug 2011 | — | Cephalon | Completed | No outcome recorded |
| Phase 1 | NCT01319266 | Mar → Oct 2011 | impaired renal function disease | Cephalon | Completed | No outcome recorded |
| Phase 1 | NCT02242734 | Feb → May 2011 | — | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02244762 | Feb → May 2011 | impaired renal function disease | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03642873 | May 2007 | — | Reckitt Benckiser Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00429468 | Jan 2007 → ? | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00853190 | Sep → Oct 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 1 | NCT02117141 | Jun 2002 | — | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01364922 | Jun → Oct 2011 | chronic pain syndrome | AbbVie | Completed | No outcome recorded |
| Phase 312 trials · 3 met primary | ||||||
| Phase 3 | NCT03586934 | Jun 2018 → Jun 2019 | substance-related disorder | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03404518 | Feb → Oct 2018 | — | Loma Linda University | Completed | No outcome recorded |
| Phase 3 | NCT03657810 | Aug 2017 → Apr 2018 | — | Charleston Laboratories, Inc | Completed | Mixed |
| Phase 3 | NCT02487108 | Aug 2015 → Mar 2016 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT02462850 | Oct 2014 → Jan 2015 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01789970 | Mar 2013 → Feb 2014 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT01780428 | Jan → Oct 2013 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01402375 | Jan 2012 → Nov 2014 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01452529 | Oct 2011 → Sep 2013 | chronic pain syndrome | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT01400139 | Jul 2011 → Aug 2013 | chronic pain syndrome | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00325949 | May 2006 → May 2007 | chronic pain syndrome | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00236535 | Dec 2003 → Oct 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT04905563 | Jun 2021 → Jan 2024 | — | Le Bonheur Children's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT03375593 | Aug 2019 → Oct 2021 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| Phase 4 | NCT03372382 | Dec 2017 → Apr 2018 | substance-related disorder | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT01974609 | Mar 2016 → Feb 2022 | carpal tunnel syndrome | Horizon Health Network | Completed | No outcome recorded |
| Phase 4 | NCT00385684 | Oct 2007 → Dec 2011 | Alzheimer disease, vascular dementia | VA Office of Research and Development | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT04176783 | Mar 2018 → Jul 2021 | — | OrthoCarolina Research Institute, Inc. | Completed | No outcome recorded |
| — | NCT01982799 | Feb 2014 → Sep 2015 | tooth disorder | University of Minnesota | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00386243 | Dec 2007 → May 2012 | chronic pain syndrome | VA Office of Research and Development | Completed | Met primary |
| Comparator or background therapy52 trials | ||||||
| Phase 0 | NCT03820193 Comparator | Jan 2019 → Jun 2020 | substance-related disorder | Henry Ford Health System | Completed | No outcome recorded |
| Phase 0 | NCT03579446 Background | Nov 2018 → Jun 2023 | hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 0 | NCT06484439 Comparator | Feb 2018 → Nov 2021 | impacted teeth, multiple, neuropathy, painful | United States Naval Medical Center, San Diego | Completed | No outcome recorded |
| Phase 0 | NCT02373254 Comparator | Jan → Oct 2015 | — | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT03640247 Background | Nov 2018 → Dec 2019 | parathyroid gland disorder, thyroid gland disorder | MetroHealth Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03137017 Comparator | Sep → Nov 2017 | substance-related disorder | Grünenthal GmbH | Withdrawn | No outcome recorded |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00802087 Comparator | Nov → Dec 2008 | — | Egalet Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00853294 Comparator | Sep 2003 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT07862595 Comparator | Nov 2026 → Jun 2027 expected | — | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06780202 Background | Jan 2025 → Jun 2027 expected | — | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06619847 Comparator | Oct 2024 → May 2025 | — | Vertex Pharmaceuticals Incorporated | Completed | Missed primary |
| Phase 2 | NCT06232577 Background | Mar 2024 → Aug 2026 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03584152 Comparator | Aug 2019 → Nov 2024 | neuropathy, painful | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT03879408 Comparator | May → Nov 2019 | — | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Completed | No outcome recorded |
| Phase 2 | NCT03173456 Comparator | Nov 2017 → Nov 2019 | musculoskeletal system disorder | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT03206723 Comparator | Jul 2017 → Dec 2018 | — | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02197156 Comparator | Aug 2002 → Feb 2003 | — | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04452344 Comparator | Jan 2021 → Jul 2023 | substance-related disorder | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 3 | NCT05283499 Comparator | Jul 2020 → Mar 2021 | — | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 3 | NCT03823534 Background | Feb 2019 → Dec 2026 expected | bone neoplasm, plasma cell myeloma, substance-related disorder | St. Louis University | Recruiting | No outcome recorded |
| Phase 3 | NCT02462811 Comparator | Sep 2014 → Jul 2015 | — | Joseph Hazelton | Completed | No outcome recorded |
| Phase 4 | NCT07575230 Comparator | Nov 2025 → Dec 2027 expected | skin neoplasm | Baylor Research Institute | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07158476 Comparator | Oct 2025 → Sep 2030 expected | — | St. Louis University | Recruiting | No outcome recorded |
| Phase 4 | NCT06935331 Comparator | Oct 2025 → Dec 2026 expected | adolescent idiopathic scoliosis | OrthoCarolina Research Institute, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05640674 Comparator | Sep 2023 → Dec 2025 | — | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05544734 Comparator | Nov 2022 → May 2023 | nail anomaly | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT04307940 Comparator | Mar → Oct 2020 | — | Bayer | Completed | Met primary |
| Phase 4 | NCT04008043 Comparator | Feb 2020 → May 2021 | — | Boston University | Withdrawn | No outcome recorded |
| Phase 4 | NCT04149964 Comparator | Nov 2019 → Sep 2022 | — | Corewell Health East | Completed | No outcome recorded |
| Phase 4 | NCT06187584 Comparator | Apr 2019 → Dec 2023 | — | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 4 | NCT03619785 Comparator | Nov 2018 → Aug 2019 | myopathy, congenital, with respiratory insufficiency and bone fractures | Andrew A Herring | Unknown | No outcome recorded |
| Phase 4 | NCT03605914 Comparator | Aug 2018 → Jul 2020 | — | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT03472469 Comparator | Apr 2018 → Jul 2019 | — | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT03457116 Comparator | Jan 2018 → Nov 2020 | — | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT05024825 Comparator | Aug 2017 → May 2021 | — | Albany Medical College | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02358850 Comparator | Jan 2016 → Jan 2019 | neuropathy, painful | University of Nebraska | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02455518 Comparator | Jul 2015 → Aug 2016 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02029235 Comparator | Feb 2015 → Nov 2017 | carpal tunnel syndrome, de Quervain disease, ganglion or cyst of synovium/tendon/bursa | Alexander Payatakes, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02296840 Comparator | Nov 2014 → Nov 2016 | drug allergy, obstructive sleep apnea syndrome, tonsillitis | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT02219581 Background | Oct 2014 → Dec 2015 | osteoarthritis | Thomas L Bradbury | Terminated | No outcome recorded |
| Phase 4 | NCT01517295 Background | Feb → May 2012 | chronic pain syndrome | NEMA Research, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01330459 Comparator | Feb → Oct 2011 | — | Elizabeth Micks | Completed | No outcome recorded |
| Phase 4 | NCT00574015 Comparator | Dec 2007 → Jan 2013 | — | Albany Medical College | Completed | No outcome recorded |
| Phase 4 | NCT01011634 Comparator | May 2007 → Nov 2008 | pregnancy disorder with abortive outcome | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00314340 Comparator | Nov 2005 → Apr 2008 | chronic pain syndrome | University of California, Davis | Completed | No outcome recorded |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT03996564 Comparator | Feb → Dec 2016 | — | San Antonio Military Medical Center | Completed | No outcome recorded |
| — | NCT02236130 Background | Jun 2014 → Jun 2015 | — | University of Mississippi Medical Center | Terminated | No outcome recorded |
| — | NCT02136784 Comparator | Apr → Dec 2014 | — | University of California, Los Angeles | Unknown | No outcome recorded |
| — | NCT02312739 Comparator | Feb 2014 → Mar 2015 | — | University of New Mexico | Completed | No outcome recorded |
| — | NCT01859715 Comparator | Jun 2012 → Jan 2013 | — | University of Colorado, Denver | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2020-08-24 | Teva Canada | Regulatory Important safety information on prescription cough and cold products containing opioids and the risk of opioid ase disorder in children and adolescents tevacanada.com ↗
Prescription cough and cold products containing codeine, hydrocodone or normethadone are NOT indicated for use in children and adolescents (younger than 18 years of age) since: |
| 2018-01-08 | Acura Pharmaceuticals Inc. | Results Acura Pharmaceuticals Announces Successful Results from Study AP-LTX-301 acurapharm.com ↗
Results demonstrated a trend toward BE for both active ingredients in LTX-03 formulations A through E, with one at no buffer and four at lower buffer strength tablets. |
| 2017-10-09 | Acura Pharmaceuticals Inc. | Results Acura Pharmaceuticals Advances LTX-03 and its LIMITx™ Technology acurapharm.com ↗
In Study 300, a single LTX-03 dose formulated without any buffer achieved a peak blood concentration (Cmax) of hydrocodone of 82% of the reference drug. |
| 2017-06-26 | Lannett Company, Inc. | Regulatory Lannett Receives Approval For Additional Dosage Strengths Of Hydrocodone Bitartrate And Acetaminophen Tablets USP investorroom.com ↗ |
| 2017-06-22 | Lannett Company, Inc. | Regulatory Lannett Receives Approval For Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg And 10 mg/300 mg investorroom.com ↗ |
| 2017-01-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved VANTRELATM ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva’s proprietary abuse deterrence technology. |
| 2016-12-04 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Norco® Tablets lupin.com ↗
Lupin Somerset (also known as Novel Laboratories, Inc.) has received final approval for its Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) |
| 2016-06-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Gains Recommendation for Approval from FDA Advisory Committees for VANTRELA™ ER (hydrocodone bitartrate) Extended-Release Tablets CII Formulated with Proprietary Abuse Deterrence Technology tevapharm.com ↗
The committees also voted: 14 to 3 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the oral route of abuse. |
| 2015-02-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance for Review of NDA for its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets with Proprietary Abuse Deterrence Technology tevapharm.com ↗ |
| 2014-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Initiation of New Drug Application and Positive Results from Second Human Abuse Liability Study for CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets tevapharm.com ↗
Teva expects to complete the NDA submission by the end of 2014. |
| 2014-09-29 | Acura Pharmaceuticals Inc. | Results Acura Pharmaceuticals Hydrocodone Bitartrate With Acetaminophen Tablets Meet Clinical Endpoints acurapharm.com ↗
Further, the studies demonstrated dose proportionality, or relatively consistent blood exposure, across all three dosage strengths of AVERSION H/A. |
| 2014-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Reports Positive Results from Pivotal Phase III Study to Evaluate Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Moderate to Severe Chronic Low Back Pain tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties (CEP-33237). |
| 2009-01-07 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma receives USFDA approvals for 4 generic products; company receives its first controlled substance product approval sunpharma.com ↗
Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. |
| 2003-04-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Hydrocodone Bitartrate and Ibuprofen Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg. |
All press releases naming this drug 15 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hydrocodone | “A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and...” NCT03567941 ↗86“The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325...” NCT02487108 ↗ “Biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) 7.5/325-mg tablets are formulated with gastroretentive ER drug delivery...” PMID 26614499 ↗ Nov 2015 “This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with...” NCT01780428 ↗ “This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of different amounts of tablets of a new and...” NCT03137030 ↗ “Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734 ↗ “Evaluation of the Effect of Renal Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02244762 ↗ “A Pilot Study in Healthy Volunteers to Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules, in Both Fed...” NCT02117141 ↗ “Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg \[(1) 40 mg tablet + (1) 120 mg tablet\] (day 15) extended-release tablets administered orally every 24 hours.” NCT02243241 ↗ “Participants were randomized to receive 5 mg of hydrocodone with 300 mg of acetaminophen (opioid) or 400 mg of ibuprofen and 500 mg of acetaminophen (nonopioid).” PMID 39755971 ↗ Jan 2025 “Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).” NCT03605914 ↗ |
| Known as | HC-ER | “Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734 ↗1“Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg Capsules” NCT02244762 ↗ |
| Known as | HYD | “The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects” NCT02243241 ↗ |
| Known as | Hydrocodon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03820193 ↗ |
| Known as | Hydrocodone Bitartrate | “An Open-Label, Single-Dose Study to Assess the Pharmacokinetics of the Hydrocodone Bitartrate Extended-Release Tablet (45 mg) in Subjects With Normal Renal Function and...” NCT01319266 ↗3“Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734 ↗ “The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects” NCT02243241 ↗ “Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg Capsules” NCT02244762 ↗ |
| Known as | Hydrocodone ER | “Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the...” NCT01789970 ↗ |
| Known as | hydrocodone/acetaminophen extended release | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01364922 ↗ |
| Route | Oral | “oral hydrocodone 10 mg/acetaminophen 650 mg” NCT00574015 ↗ |