Tools / Drug approvals and letters / Drugs Metoclopramide Hydrochloride Sold as Reglan, Reglan Odt, Metozolv Odt, Gimoti. Every FDA application for this active ingredient: 6 branded and 61 generic.
As of Nov 15, 2026, FDA lists 67 applications for Metoclopramide Hydrochloride (sold as Reglan, Reglan Odt, Metozolv Odt and others), first approved Feb 7, 1979, with 7 new uses approved and 1 published complete response letter.
First approved : Feb 7, 1979 Applications : 67 New uses approved : 7 Complete response letters : 1 Medicare spending, 2025 : $16.0M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Metoclopramide HCl Part D $8.8M +7% 413,708 Gimoti Part D $7.1M +55% 1,029 Reglan Part D $59K -13% 44 Metoclopramide HCL Part B $4K -5% 1,538
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 METOCLOPRAMIDE 10 MG TABLET: $0.043 per unit Generic · -12% in a year METOCLOPRAMIDE 10 MG/2 ML VIAL: $0.529 per ML Generic · -7% in a year METOCLOPRAMIDE 5 MG TABLET: $0.035 per unit Generic · -18% in a year METOCLOPRAMIDE 5 MG/5 ML SOLN: $0.130 per ML Generic · +6% in a year Clinical Trials 21 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia · Sanliurfa Education and Research Hospital Phase 4 Recruiting Jul 31, 2026 Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy Postoperative Nausea and Vomiting · Faisalabad Medical University Phase 4 Recruiting Jun 10, 2026 Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment Concussion Post Syndrome, Head Trauma Injury · Montefiore Medical Center Phase 4 Not yet recruiting Jun 8, 2026 Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients Gastrointestinal Dysfunction, Malnutrition · Arma Ltd. — Not yet recruiting Jun 3, 2026 Dexamethasone Plus Metoclopramide Versus Paracetamol/NSAIDs for Primary Headache Primary Headache · Pak Emirates Military Hospital Phase 4 Not yet recruiting May 22, 2026 Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy Postoperative Nausea and Vomiting (PONV) · Assiut University Phase 4 Not yet recruiting Jan 22, 2026 IV Injection of Metoclopramide With or Without Dexamethasone Trauma Injury · Ahmed Nassar Ibrahim Mohammed Early phase 1 Not yet recruiting Jan 15, 2026 Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting Nausea, Vomiting · Affiliated Hospital of Qinghai University Phase 3 Recruiting Oct 6, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Feb 7, 1979 Reglan NDA 17862 · New molecular entity 47 Discontinued Dec 30, 1980 Reglan NDA 17854 · New dosage form 52 Marketed Mar 25, 1983 Reglan NDA 18821 · New dosage form 20 Discontinued Jul 29, 1985 Metoclopramide Hydrochloride ANDA 70184 43 Marketed Oct 17, 1985 Metoclopramide Hydrochloride ANDA 70581 23 Discontinued Oct 28, 1985 Clopra-"Yellow" ANDA 70632 0 Discontinued Jan 22, 1986 Metoclopramide Hydrochloride ANDA 70511 10 Discontinued Jan 24, 1986 Metoclopramide Hydrochloride ANDA 70293 2 Discontinued Feb 2, 1987 Metoclopramide Hydrochloride ANDA 70598 0 Discontinued Feb 10, 1987 Metoclopramide Hydrochloride ANDA 70660 13 Discontinued Mar 2, 1987 Metoclopramide Hydrochloride ANDA 70622 1 Discontinued Jun 26, 1987 Metoclopramide Hydrochloride ANDA 70926 6 Discontinued Jul 10, 1987 Metoclopramide Hydrochloride ANDA 70819 20 Discontinued Feb 3, 1988 Metoclopramide Hydrochloride ANDA 71250 17 Discontinued Aug 18, 1988 Metoclopramide Hydrochloride ANDA 71340 19 Discontinued Aug 26, 1988 Metoclopramide Hydrochloride ANDA 70892 0 Discontinued Nov 7, 1988 Metoclopramide Hydrochloride ANDA 70847 11 Discontinued Dec 5, 1988 Metoclopramide Hydrochloride ANDA 72038 13 Discontinued Mar 3, 1989 Metoclopramide Hydrochloride ANDA 71291 9 Discontinued Jun 22, 1989 Metoclopramide Hydrochloride ANDA 70506 3 Discontinued Jun 23, 1989 Metoclopramide Hydrochloride ANDA 70505 2 Discontinued Jan 30, 1990 Metoclopramide Hydrochloride ANDA 72215 4 Marketed Jan 17, 1991 Metoclopramide Hydrochloride ANDA 73117 7 Discontinued Jan 17, 1991 Metoclopramide Hydrochloride ANDA 73118 17 Marketed May 9, 1991 Metoclopramide Hydrochloride ANDA 72639 0 Discontinued May 28, 1991 Metoclopramide Hydrochloride ANDA 72744 11 Marketed Nov 27, 1991 Metoclopramide Hydrochloride ANDA 73135 10 Marketed Jan 30, 1992 Metoclopramide Intensol ANDA 72995 2 Discontinued Oct 27, 1992 Metoclopramide Hydrochloride ANDA 73680 16 Discontinued Apr 28, 1993 Metoclopramide Hydrochloride ANDA 71536 25 Discontinued Jun 15, 1993 Metoclopramide Hydrochloride ANDA 72801 26 Marketed Jun 25, 1993 Metoclopramide Hydrochloride ANDA 71402 8 Marketed Jun 28, 1993 Metoclopramide Hydrochloride ANDA 70949 7 Discontinued Jun 30, 1993 Metoclopramide Hydrochloride ANDA 71315 1 Discontinued Oct 5, 1995 Metoclopramide Hydrochloride ANDA 74478 6 Discontinued Aug 2, 1996 Metoclopramide Hydrochloride ANDA 74147 5 Discontinued Oct 31, 1997 Metoclopramide Hydrochloride ANDA 74703 10 Discontinued Jan 26, 2001 Metoclopramide Hydrochloride ANDA 75051 3 Discontinued Jun 10, 2005 Reglan Odt NDA 21793 · New dosage form 6 Discontinued Aug 28, 2006 Metoclopramide Hydrochloride ANDA 77878 5 Marketed Nov 30, 2007 Metoclopramide Hydrochloride ANDA 78374 6 Discontinued Jun 12, 2008 Metoclopramide Hydrochloride ANDA 78807 7 Marketed Sep 4, 2009 Metozolv Odt NDA 22246 · New dosage form 5 Discontinued Apr 19, 2013 Metoclopramide Hydrochloride ANDA 91392 2 Marketed Dec 20, 2013 Metoclopramide ANDA 204756 0 Marketed Aug 15, 2014 Metoclopramide Hydrochloride ANDA 202191 1 Marketed Jun 19, 2020 Gimoti NDA 209388 · TYPE 3/4 2 Marketed Sep 11, 2026 Metoclopramide Hydrochloride ANDA 217072 0 Marketed — Metoclopramide Hydrochloride ANDA 71665 0 Discontinued — Metoclopramide Hydrochloride ANDA 72155 0 Discontinued — Maxolon ANDA 70106 0 Discontinued — Metoclopramide Hydrochloride ANDA 70363 0 Discontinued — Metoclopramide Hydrochloride ANDA 70342 3 Discontinued — Clopra ANDA 70294 0 Discontinued — Metoclopramide Hydrochloride ANDA 70339 0 Discontinued — Metoclopramide Hydrochloride ANDA 70453 0 Discontinued — Metoclopramide Hydrochloride ANDA 70623 0 Discontinued — Metoclopramide Hydrochloride ANDA 70645 0 Discontinued — Metoclopramide Hcl ANDA 70671 0 Discontinued — Metoclopramide Hydrochloride ANDA 70850 0 Discontinued — Metoclopramide Hydrochloride ANDA 70906 0 Discontinued — Metoclopramide Hydrochloride ANDA 71213 0 Discontinued — Metoclopramide Hydrochloride ANDA 71990 0 Discontinued — Metoclopramide Hydrochloride ANDA 72244 0 Discontinued — Metoclopramide Hydrochloride ANDA 72247 0 Discontinued — Clopra ANDA 72384 0 Discontinued — Metoclopramide Hydrochloride ANDA 72436 0 Discontinued
Complete Response Letters FDA's published letters for these applications 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
Hikma
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Schering
Impax Labs Inc
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Sun Pharm Industries
Fresenius Kabi USA
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Par Pharm
Sandoz