Prescription medicine
Morphine Brand names: Duramorph, Infumorph, Mitigo; first approved as Duramorph Pf
Morphine (Duramorph) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.226 per morphine sulfate ir 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the morphine FDA label on DailyMed (effective July 13, 2026, Bryant Ranch Prepack); the NDA 18565 record on Drugs@FDA; every morphine label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME.
and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Morphine sulfate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate extended-release tablets, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2)]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. […]
Used for
From the label: indications and usageMorphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Forms and strengths
- 15 mg
- 20 mg
- 30 mg
- 40 mg
- 50 mg
- 60 mg
- 75 mg
- 80 mg
- 100 mg
- 200 mg
- 0.5 mg/ml
- 1 mg/ml
Film-coated extended-release tablet; extended-release capsule; solution; injection (solution); tablet.
On the market
- Earliest approval on file
- September 18, 1984 Duramorph Pf, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 59 first October 7, 1986; 22 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 22 under generic applications, 9 under brand applications, repackagers included
- Last listed patent
- March 12, 2034 Morphine Sulfate injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.226 per tablet Morphine sulfate ir 15 mg tablet
- Shortage (FDA)
- 12 of 30 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 66 since 2010 8 Class I among all firms' recalls; latest August 4, 2026; 79 more by firms not listed as its makers
- FAERS reports
- 120,591 through July 30, 2026
What is morphine used for?
From the label: indications and usageMorphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. […]
Conditions named in the indications of morphine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Morphine sulfate), ANDA078761 (Sun Pharm Inds Ltd), as published by Bryant Ranch Prepack, effective July 13, 2026 (SPL set 595243fe-a4b1-479a-99d6-a084a4181891), via openFDA; the full label on DailyMed
Is there a generic for morphine (Duramorph)?
The FDA approved the first generic morphine on October 7, 1986. 59 generic applications are approved; 22 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists morphine from 22 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Duramorph Pf injection; a patent listed only for Morphine Sulfate injection runs to March 12, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1984 earliest approval on file
- 1986 first generic approved
- 2034 last listed patent
- 2017 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for morphine (Duramorph)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.226 per Morphine sulfate ir 15 mg tablet, down 12% from $0.256 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Morphine sulf 100 mg/5 mL conc (generic)
- Ms contin ER 15 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Morphine sulf 10 mg/5 mL solution | Generic | $0.0673 per mL | n/a | +3% |
| Morphine sulf 100 mg/5 mL conc | Generic | $0.392 per mL | n/a | -5% |
| Morphine sulf 20 mg/5 mL solution | Generic | $0.120 per mL | n/a | +25% |
| Morphine sulf ER 100 mg tablet | Generic | $0.854 per tablet | $25.62 | -9% |
| Morphine sulf ER 15 mg tablet | Generic | $0.310 per tablet | $9.30 | -4% |
| Morphine sulf ER 200 mg tablet | Generic | $2.13 per tablet | $63.80 | -11% |
| Morphine sulf ER 30 mg tablet | Generic | $0.441 per tablet | $13.24 | +3% |
| Morphine sulf ER 60 mg tablet | Generic | $0.657 per tablet | $19.70 | +11% |
| Morphine sulfate 10 mg/mL vial | Generic | $2.34 per mL | n/a | +0.3% |
| Morphine sulfate 4 mg/mL vial | Generic | $2.32 per mL | n/a | +2% |
| Morphine sulfate ER 10 mg capsule | Generic | $2.61 per capsule | $78.17 | -11% |
| Morphine sulfate ER 20 mg capsule | Generic | $3.08 per capsule | $92.43 | +5% |
| Morphine sulfate ir 15 mg tablet | Generic | $0.226 per tablet | $6.77 | -12% |
| Morphine sulfate ir 30 mg tablet | Generic | $0.341 per tablet | $10.24 | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is morphine in shortage?
The FDA Drug Shortage Database lists 12 of 30 morphine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on October 31, 2017. 12 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Duramorph, Injection, .5 mg/1 mL (NDC 0641-6020-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Duramorph, Injection, 1 mg/1 mL (NDC 0641-6019-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Infumorph 200 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 10 mg/1 mL (NDC 0641-6039-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Infumorph 500 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 25 mg/1 mL (NDC 0641-6040-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Mitigo, Injection, 200 mg/20 mL (NDC 66794-160-02) | Piramal Critical Care Inc. | Current | September 15, 2026 |
| Mitigo, Injection, 500 mg/20 mL (NDC 66794-162-02) | Piramal Critical Care Inc. | Current | September 15, 2026 |
| Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1) | Amphastar Pharmaceuticals, Inc. | Current | October 5, 2026 |
| Morphine Sulfate, Injection, 10 mg/1 mL (NDC 0641-6127-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has morphine been recalled?
The FDA's Enforcement Report lists 145 recalls naming morphine since 2010: 8 Class I (the most serious), 127 Class II, 10 Class III; 7 still ongoing. 79 of them are by firms that FDA's NDC Directory does not list as a maker of morphine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 4, 2026 | Class I | Fresenius Kabi USA, LLC | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. |
| November 26, 2025 | Class III | Winder Laboratories, LLC | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. |
| February 17, 2025 | Class II | Safecor Health, LLC | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. |
| February 6, 2025 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications |
| October 22, 2024 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specification |
| March 12, 2024 | Class II | Hikma Pharmaceuticals USA Inc. | The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. |
| October 20, 2023 | Class III | Edenbridge Pharmaceuticals, LLC not a listed maker | Subpotent Drug |
| December 27, 2022 | Class II | Sentara Infusion Services | Lack of sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the morphine label say about other medicines?
The morphine label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 31 other medicines name morphine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of morphine sulfate and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of morphine sulfate and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Cimetidine | drug interactions | Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. … Warnings and Precautions (5.3, 5.5)] Examples: Cyclobenzaprine, metaxalone Cimetidine |
| Clopidogrel | drug interactions | Oral P2Y 12 Inhibitors Clinical Impact: The co-administration of oral P2Y 12 inhibitors and intravenous morphine sulfate can decrease the absorption and peak concentration of oral P2Y 12 inhibitors and delay the onset of antiplatelet effect. Intervention: Consider the use of a parenteral antiplatelet agent in the setting of acute coronary syndrome requiring co-administration of intravenous morphine sulfate. Examples: clopidogrel, prasugrel, ticagrelor |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Hydrocodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … titration of small doses of other opioids (such as oxycodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of morphine sulfate and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2, 2.5), Warnings and Precautions (5.1, 5.3 … |
Every other medicine the morphine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Oxycodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … test doses and frequent titration of small doses of other opioids (such as oxycodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and … |
| Oxymorphone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … and frequent titration of small doses of other opioids (such as oxycodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: Do not use morphine sulfate in patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| Prasugrel | drug interactions | Oral P2Y 12 Inhibitors Clinical Impact: The co-administration of oral P2Y 12 inhibitors and intravenous morphine sulfate can decrease the absorption and peak concentration of oral P2Y 12 inhibitors and delay the onset of antiplatelet effect. Intervention: Consider the use of a parenteral antiplatelet agent in the setting of acute coronary syndrome requiring co-administration of intravenous morphine sulfate. Examples: clopidogrel, prasugrel, ticagrelor |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Quinidine | drug interactions | P-Glycoprotein (P-gp) Inhibitors Clinical Impact: The concomitant use of PGP-inhibitors can increase the exposure to morphine by about two-fold and can increase risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: Evaluate patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of morphine sulfate and/or the PGP-inhibitor as necessary. Example: Quinidine |
| Ticagrelor | drug interactions | Oral P2Y 12 Inhibitors Clinical Impact: The co-administration of oral P2Y 12 inhibitors and intravenous morphine sulfate can decrease the absorption and peak concentration of oral P2Y 12 inhibitors and delay the onset of antiplatelet effect. Intervention: Consider the use of a parenteral antiplatelet agent in the setting of acute coronary syndrome requiring co-administration of intravenous morphine sulfate. Examples: clopidogrel, prasugrel, ticagrelor |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: Do not use morphine sulfate in patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Verapamil | drug interactions | P-Glycoprotein (P-gp) Inhibitors Clinical Impact: The concomitant use of P-gp inhibitors can increase the exposure to morphine by two-fold and can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … Oral Solution and/or the P-gp inhibitor as necessary. Examples: Quinidine, verapamil. |
Other labels that name morphine
- Acetaminophen and caffeine and dihydrocodeine
- Baclofen
- Codeine
- Dinutuximab
- Ethinyl estradiol and etonogestrel
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Gabapentin enacarbil
- Midazolam
- Pralidoxime
Source: FDA drug label (Morphine sulfate), ANDA078761 (Sun Pharm Inds Ltd), as published by Bryant Ranch Prepack, effective July 13, 2026 (SPL set 595243fe-a4b1-479a-99d6-a084a4181891), via openFDA; the full label on DailyMed
What do FAERS reports show for morphine?
The FDA Adverse Event Reporting System holds 120,591 reports that list morphine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 34,831 are coded as a death and 22,989 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (26,861, against a median of 4,938 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as morphine?
36 other medicines are given the same way (oral) and in the same FDA class as morphine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does morphine compare with medicines for the same use?
15 side-by-side pages set morphine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to morphine
- 36 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Morphine side effects
- the label's list beside FAERS reports
- Morphine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other