Tools / Drug approvals and letters / Drugs Meperidine Hydrochloride Manages pain severe enough to require an opioid analgesic. Sold as Demerol. Every FDA application for this active ingredient: 2 branded and 42 generic.
As of Nov 15, 2026, FDA lists 44 applications for Meperidine Hydrochloride (sold as Demerol), first approved Nov 10, 1942, with 0 new uses approved and 0 published complete response letters.
First approved : Nov 10, 1942 Applications : 44 New uses approved : 0 Complete response letters : 0 Medicare spending, 2025 : $1.7M Shortage : Current
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Meperidine HCl Part D $1.7M +42% 1,187 Demerol Part B $24K -33% 1,492
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change MEPERIDINE 50 MG/5 ML SOLUTION: $0.157 per ML Generic · +2% in a year
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Cold Therapy Following Laparoscopic Cholecystectomy Cold Therapy Following Laparoscopic Cholecystectomy, Pain, Sleep Quality, Quality of Postoperative Recovery · Mersin University Not applicable Not yet recruiting Nov 12, 2026 Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia Shivering, Hypothermia · Assiut University Phase 4 Not yet recruiting Oct 2, 2026 TAP vs. ESP Blocks for Post-Cesarean Analgesia Postoperative Pain After Cesarean Section · Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog Not applicable Not yet recruiting Oct 1, 2026 Adductor Canal Block Versus Parasartorial Compartment Block for Pain Relief and Recovery After Arthroscopic Knee Surgery Postoperative Pain After Arthroscopic Knee Surgery · Istanbul Medipol University Hospital Not applicable Not yet recruiting Aug 27, 2026 Quadro-Iliac Plane Block for Pain Control After Posterior Spinal Instrumentation Surgery Posterior Spinal Instrumentation Patients · Istanbul Medipol University Hospital Early phase 1 Not yet recruiting Jul 17, 2026 Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2% Postoperative Pain, Postoperative Acute Pain · Matild Keresztes Not applicable Recruiting May 22, 2026 TEAS for Sedation During ERCP: A Multicenter Trial With Mechanistic Substudy Endoscopic Retrograde Cholangiopancreatography, Conscious Sedation Adverse Event · Beijing 302 Hospital Not applicable Not yet recruiting Feb 27, 2026 Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block Shoulder Pain, Shoulder Disease · Medipol University Not applicable Recruiting Dec 11, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Nov 10, 1942 Demerol NDA 5010 · New molecular entity 53 Discontinued Nov 10, 1942 Demerol NDA 21171 13 Marketed Apr 26, 1972 Meperidine Hydrochloride ANDA 80455 9 Marketed Jul 31, 1973 Meperidine Hydrochloride ANDA 80454 10 Discontinued Jan 22, 1975 Meperidine Hydrochloride ANDA 80445 16 Marketed May 19, 1976 Meperidine Hydrochloride ANDA 80364 0 Discontinued Oct 15, 1976 Meperidine Hydrochloride ANDA 80448 10 Discontinued Jun 15, 1984 Meperidine Hydrochloride ANDA 88280 1 Discontinued Jun 15, 1984 Meperidine Hydrochloride ANDA 88281 1 Discontinued Jun 15, 1984 Meperidine Hydrochloride ANDA 88282 1 Discontinued Jun 15, 1984 Meperidine Hydrochloride ANDA 88279 1 Discontinued Jul 2, 1984 Meperidine Hydrochloride ANDA 88639 35 Discontinued Aug 16, 1984 Meperidine Hydrochloride Preservative Free ANDA 88432 8 Discontinued Sep 19, 1984 Meperidine Hydrochloride ANDA 88640 37 Discontinued Jan 30, 1985 Meperidine Hydrochloride ANDA 88744 28 Marketed Mar 17, 1992 Meperidine Hydrochloride Preservative Free ANDA 73443 5 Discontinued Mar 17, 1992 Meperidine Hydrochloride ANDA 73444 6 Discontinued Mar 17, 1992 Meperidine Hydrochloride ANDA 73445 5 Discontinued Jul 30, 1993 Meperidine Hydrochloride Preservative Free ANDA 81002 12 Marketed Aug 30, 1993 Meperidine Hydrochloride Preservative Free ANDA 81309 13 Discontinued Mar 12, 1997 Meperidine Hydrochloride ANDA 40110 16 Discontinued May 12, 1997 Meperidine Hydrochloride Preservative Free ANDA 40163 5 Discontinued Jun 30, 1997 Meperidine Hydrochloride ANDA 40186 13 Discontinued Dec 17, 1998 Meperidine Hydrochloride ANDA 40191 15 Discontinued Mar 10, 1999 Meperidine Hydrochloride Preservative Free ANDA 40305 2 Discontinued May 28, 1999 Meperidine Hydrochloride ANDA 40331 15 Marketed Oct 5, 1999 Meperidine Hydrochloride ANDA 40318 0 Discontinued Jun 13, 2000 Meperidine Hydrochloride ANDA 40352 3 Discontinued Aug 8, 2002 Meperidine Hydrochloride ANDA 40446 10 Discontinued Jun 24, 2009 Meperidine Hydrochloride ANDA 40893 7 Marketed — Meperidine Hydrochloride ANDA 80385 0 Discontinued — Meperidine Hydrochloride ANDA 80386 0 Discontinued — Meperidine Hydrochloride ANDA 80387 0 Discontinued — Meperidine Hydrochloride ANDA 80388 0 Discontinued — Meperidine Hydrochloride ANDA 80389 0 Discontinued — Meperidine Hydrochloride ANDA 86332 0 Discontinued — Meperidine Hydrochloride ANDA 89781 0 Discontinued — Meperidine Hydrochloride ANDA 89782 0 Discontinued — Meperidine Hydrochloride ANDA 89783 0 Discontinued — Meperidine Hydrochloride ANDA 89784 0 Discontinued — Meperidine Hydrochloride ANDA 89785 0 Discontinued — Meperidine Hydrochloride ANDA 89786 0 Discontinued — Meperidine Hydrochloride ANDA 89787 0 Discontinued — Meperidine Hydrochloride ANDA 89788 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
Parke Davis
Sun Pharm Industries
Baxter Hlthcare
Hikma
Strides Pharma Intl
Abbott