Tools / Drug approvals and letters / Drugs Morphine Sulfate Manages intractable chronic pain severe enough to require an opioid analgesic. Sold as Duramorph Pf, Infumorph, Ms Contin, Morphine Sulfate, Oramorph Sr and 5 more. Every FDA application for this active ingredient: 17 branded and 59 generic.
As of Nov 15, 2026, FDA lists 76 applications for Morphine Sulfate (sold as Duramorph Pf, Infumorph, Ms Contin and others), first approved Sep 18, 1984, with 5 new uses approved and 0 published complete response letters.
First approved : Sep 18, 1984 Applications : 76 New uses approved : 5 Complete response letters : 0 Medicare spending, 2025 : $64.8M Shortage : Current
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Morphine Sulfate ER Part D $48.9M -16% 228,922 Morphine Sulfate Part D $15.0M -12% 229,948 Ms Contin Part D $832K +16% 780 Morphine Sulfate (J2270) Part B $47K +19% 3,162 Morphine Sulfate (J2272) Part B $2K -100% 96
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 MORPHINE SULFATE 10 MG/ML VIAL: $2.34 per ML Generic · +3% in a year MORPHINE SULFATE 4 MG/ML VIAL: $2.32 per ML Generic · +2% in a year MORPHINE SULFATE ER 10 MG CAP: $2.61 per unit Generic · -11% in a year MORPHINE SULFATE ER 20 MG CAP: $3.08 per unit Generic · +5% in a year MS CONTIN ER 15 MG TABLET: $4.65 per unit Brand · -1% in a year MS CONTIN ER 30 MG TABLET: $8.95 per unit Brand · +1% in a year FDA Drug Safety Communications 2 communications since 2020 that name this drug; see all communications
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 286 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Magnesium-Enhanced ESPB for Respiratory Recovery and Analgesia in Unilateral Rib Fractures Unilateral Rib Fracture, ESPB · Assiut University Not applicable Not yet recruiting Nov 10, 2026 Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital Cesarean Section · Assiut University Phase 4 Active, not recruiting Nov 6, 2026 Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study Cancer Pain, Orofacial Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre Phase 2 Recruiting Nov 5, 2026 Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery Multimodal Analgesia, Tramadol · Centre Hospitalier Universitaire, Amiens Not applicable Recruiting Nov 3, 2026 Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty Postoperative Pain, Hip Arthroplasty, Total · Uludag University Not applicable Not yet recruiting Oct 29, 2026 Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia · Beth Israel Deaconess Medical Center Phase 4 Not yet recruiting Oct 29, 2026 Implementation of a Pain Management Plan in Major Open Abdominal Surgeries. Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H) · National and Kapodistrian University of Athens Not applicable Recruiting Oct 28, 2026 Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb Lower Limb Surgery, Pain · Aga Khan University Phase 4 Not yet recruiting Oct 27, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Sep 18, 1984 Duramorph Pf, Infumorph NDA 18565 · New dosage form 23 Marketed Oct 7, 1986 Astramorph Pf ANDA 71050 8 Discontinued Oct 7, 1986 Astramorph Pf ANDA 71053 9 Discontinued Oct 7, 1986 Astramorph Pf ANDA 71051 9 Discontinued Oct 7, 1986 Astramorph Pf ANDA 71052 9 Discontinued May 29, 1987 Ms Contin NDA 19516 · New dosage form 40 Marketed May 11, 1988 Morphine Sulfate ANDA 71849 6 Discontinued May 11, 1988 Morphine Sulfate ANDA 71850 6 Discontinued Jul 12, 1990 Morphine Sulfate NDA 19999 · New formulation or manufacturer 13 Discontinued Aug 15, 1991 Oramorph Sr NDA 19977 · New formulation or manufacturer 5 Discontinued Sep 30, 1991 Morphine Sulfate ANDA 73373 5 Discontinued Sep 30, 1991 Morphine Sulfate ANDA 73374 5 Discontinued Sep 30, 1991 Morphine Sulfate ANDA 73375 4 Discontinued Sep 30, 1991 Morphine Sulfate ANDA 73376 4 Discontinued Sep 30, 1992 Morphine Sulfate ANDA 73509 10 Marketed Sep 30, 1992 Morphine Sulfate ANDA 73510 10 Marketed Oct 30, 1992 Morphine Sulfate NDA 19916 · New formulation or manufacturer 7 Discontinued Oct 30, 1992 Morphine Sulfate NDA 19917 · New formulation or manufacturer 4 Discontinued Jul 3, 1996 Kadian NDA 20616 · New dosage form 33 Discontinued Jul 3, 1996 Morphine Sulfate NDA 20631 · New formulation or manufacturer 3 Discontinued Jul 2, 1998 Morphine Sulfate ANDA 74769 17 Marketed Jul 7, 1998 Morphine Sulfate ANDA 74862 17 Marketed Oct 28, 1998 Morphine Sulfate ANDA 75295 26 Discontinued Jan 28, 2000 Morphine Sulfate ANDA 75407 0 Marketed Jan 30, 2001 Morphine Sulfate ANDA 75656 5 Discontinued Mar 20, 2002 Avinza NDA 21260 · New dosage form 10 Discontinued Jul 3, 2003 Morphine Sulfate ANDA 76438 25 Marketed Jul 31, 2003 Morphine Sulfate ANDA 76412 25 Marketed May 18, 2004 Depodur NDA 21671 · New dosage form 6 Discontinued May 19, 2004 Morphine Sulfate ANDA 76733 11 Discontinued May 19, 2004 Morphine Sulfate ANDA 76720 12 Discontinued Sep 27, 2007 Morphine Sulfate ANDA 77855 11 Discontinued Mar 17, 2008 Morphine Sulfate NDA 22195 · TYPE 7 18 Marketed Mar 17, 2008 Morphine Sulfate NDA 22207 · TYPE 7 12 Marketed Jun 23, 2011 Morphine Sulfate NDA 201517 · New dosage form 10 Discontinued Jul 15, 2011 Morphine Sulfate ANDA 202348 8 Marketed Oct 18, 2011 Morphine Sulfate ANDA 200824 12 Discontinued Nov 10, 2011 Morphine Sulfate ANDA 200812 14 Discontinued Nov 14, 2011 Morphine Sulfate NDA 202515 · TYPE 7 8 Marketed Jan 5, 2012 Morphine Sulfate ANDA 201947 1 Discontinued May 11, 2012 Morphine Sulfate ANDA 78761 11 Marketed Aug 6, 2012 Morphine Sulfate ANDA 201574 3 Discontinued Jan 16, 2013 Morphine Sulfate ANDA 79040 22 Marketed Jun 3, 2013 Morphine Sulfate ANDA 202104 15 Marketed Oct 30, 2013 Morphine Sulfate NDA 204223 · New formulation or manufacturer 9 Marketed Feb 5, 2014 Morphine Sulfate ANDA 201011 3 Discontinued Dec 29, 2014 Morphine Sulfate ANDA 202718 14 Discontinued Apr 6, 2015 Morphine Sulfate ANDA 203849 7 Discontinued May 12, 2015 Morphine Sulfate ANDA 203518 3 Marketed May 21, 2015 Morphine Sulfate ANDA 205758 0 Marketed Oct 2, 2015 Morphabond Er NDA 206544 · New formulation or manufacturer 10 Discontinued Oct 30, 2015 Morphine Sulfate ANDA 202310 3 Discontinued Nov 25, 2015 Morphine Sulfate ANDA 202309 1 Discontinued Dec 16, 2015 Morphine Sulfate ANDA 203602 11 Discontinued Apr 12, 2016 Morphine Sulfate ANDA 200411 16 Discontinued May 18, 2016 Morphine Sulfate ANDA 203519 1 Discontinued Jun 23, 2016 Morphine Sulfate ANDA 91357 5 Discontinued Jul 12, 2016 Morphine Sulfate ANDA 206420 2 Discontinued Aug 25, 2016 Morphine Sulfate ANDA 205634 5 Discontinued Oct 28, 2016 Morphine Sulfate ANDA 205386 2 Discontinued Nov 14, 2016 Morphine Sulfate ANDA 206573 8 Marketed Jan 9, 2017 Arymo Er NDA 208603 · New formulation or manufacturer 5 Discontinued Jun 22, 2017 Morphine Sulfate ANDA 206308 2 Discontinued Jul 6, 2017 Morphine Sulfate ANDA 208809 5 Discontinued Apr 17, 2018 Morphine Sulfate ANDA 205509 3 Discontinued Jul 16, 2018 Mitigo ANDA 204393 3 Marketed Jul 22, 2019 Morphine Sulfate ANDA 210610 2 Marketed Dec 3, 2020 Morphine Sulfate ANDA 212451 2 Marketed Feb 12, 2021 Morphine Sulfate ANDA 211454 3 Marketed Apr 29, 2021 Morphine Sulfate ANDA 202861 3 Marketed Aug 4, 2021 Morphine Sulfate ANDA 203158 5 Discontinued Jan 12, 2022 Morphine Sulfate ANDA 207270 0 Discontinued Feb 7, 2022 Morphine Sulfate ANDA 215584 2 Discontinued Jan 12, 2023 Morphine Sulfate ANDA 211452 0 Marketed Aug 21, 2023 Morphine Sulfate ANDA 215194 2 Marketed Jul 7, 2026 Morphine Sulfate ANDA 213892 0 Marketed
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
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