Manages severe and persistent pain. Sold as Zohydro Er, Hysingla Er, Vantrela Er. Every FDA application for this active ingredient: 3 branded and 3 generic.
As of Nov 15, 2026, FDA lists 6 applications for Hydrocodone Bitartrate (sold as Zohydro Er, Hysingla Er, Vantrela Er), first approved Oct 25, 2013, with 0 new uses approved and 0 published complete response letters.
| Hysingla ER | Part D | $14.6M | -21% | 3,139 |
| Hydrocodone Bitartrate ER | Part D | $1.4M | -62% | 1,176 |
| A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)Pain Management · Merck Sharp & Dohme LLC | Phase 2 | Not yet recruiting | Oct 7, 2026 |
| Nerve Block for Severe Abdominal Pain in the Emergency DepartmentErector Spinae Plane Block · University of California, Irvine | Early phase 1 | Recruiting | Sep 17, 2026 |
| A Clinical Trial of GRT7040 in Adults With Acute Pain Following BunionectomyAcute Pain, Bunionectomy · Grünenthal GmbH | Phase 2 | Not yet recruiting | Sep 8, 2026 |
| Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement SurgeryKnee Arthroplasty, Total, Post Operative Pain, Acute · Endeavor Health | Phase 4 | Not yet recruiting | Sep 1, 2026 |
| Suzetrigine vs Norco-postoperative Mohs PainCutaneous Tumors, Mohs Micrographic Surgery · Baylor Research Institute | Phase 4 | Enrolling by invitation | May 8, 2026 |
| Cold and Compression After Rotator Cuff Repair (RCR)High-grade Partial or Full Thickness Rotator Cuff Tears · Ochsner Health System | Not applicable | Recruiting | Apr 8, 2026 |
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain ServicePostsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco | Phase 3 | Not yet recruiting | Dec 22, 2025 |
| RCT: Suzetrigine vs Norco for Post-op PainPain Control · Jacob Lensing | Phase 4 | Not yet recruiting | Sep 29, 2025 |
| Oct 25, 2013 | Zohydro ErNDA 202880 · New dosage form | Recro Gainesville | 13 | Discontinued |
| Nov 20, 2014 | Hysingla ErNDA 206627 · New dosage form | Knoa Pharma | 14 | Marketed |
| Jan 17, 2017 | Vantrela ErNDA 207975 · New dosage form | Teva Branded Pharm | 1 | Discontinued |
| Jan 21, 2020 | Hydrocodone BitartrateANDA 206986 | Alvogen | 6 | Marketed |
| Mar 1, 2021 | Hydrocodone BitartrateANDA 208269 | Alvogen | 2 | Marketed |
| — | Hydrocodone BitartrateANDA 206952 | Actavis Labs Fl Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
