Skip to the answer

Duloxetine

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) used for major depressive disorder, generalized anxiety disorder, and several kinds of long-lasting pain, including diabetic nerve pain, fibromyalgia, and chronic musculoskeletal pain.

Brand names CymbaltaDrizalma SprinkleIrenkaDrizalmaNa
Drug classes Norepinephrine Uptake Inhibitors
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 141 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 15
Duloxetine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Duloxetine (Cymbalta) is an SNRI, boosting the brain chemicals serotonin and norepinephrine, used for depression, generalized anxiety disorder, diabetic nerve pain, fibromyalgia and chronic low back or arthritis pain; available as a generic and around since about 2004, it is a familiar choice when mood and long-lasting pain overlap. Most people tolerate it reasonably well; early nausea is the usual complaint and tends to settle, with dry mouth, sleepiness and sweating also common. Its boxed warning covers suicidal thoughts and behavior in children, teens and young adults, so watch mood closely early on, and never stop it suddenly, because withdrawal-type symptoms are common and unpleasant.

Clinical pearls

  • Swallow the capsule whole, since crushing, chewing or opening it damages the coating, though Drizalma Sprinkle can be opened onto applesauce.
  • Heavy drinking is a reason to avoid duloxetine, as is chronic liver disease, because of its risk of liver injury.
  • Ciprofloxacin, fluvoxamine and cimetidine can sharply raise duloxetine levels, so remind any prescriber you take it before starting one.
  • Expect blood pressure checks before and during treatment, and with diabetic nerve pain, watch your blood sugar too.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Antidepressants like duloxetine can increase suicidal thoughts and behavior in children, teens, and young adults (up to age 24). In adults over 24 this increase was not seen, and in people 65 and older the risk was lower.

Anyone starting an antidepressant should be watched closely for worsening mood or new suicidal thoughts, especially in the first few months and after dose changes. Families and caregivers should watch for agitation, irritability, or unusual behavior changes and contact the prescriber right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asDelayed-release capsule
Earliest FDA record2004
Companies listing it with the FDA41
FDA label last updatedMay 14, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Duloxetine, written from its FDA label.

What Duloxetine is used for

▾

Duloxetine is approved for several mood and pain conditions across its products.

  • Major depressive disorder in adults
  • Generalized anxiety disorder in adults, and in children 7 and older for Cymbalta, Drizalma Sprinkle, and some other duloxetine delayed-release capsules
  • Diabetic peripheral neuropathic pain in adults
  • Fibromyalgia: adults for Drizalma Sprinkle; adults and teens 13 and older for Cymbalta and some other duloxetine products
  • Chronic musculoskeletal pain in adults, including chronic low back pain and osteoarthritis pain

How Duloxetine works

▾

Duloxetine blocks the re-absorption of serotonin and norepinephrine in the brain and spinal cord, which leaves more of these chemicals active. This is believed to improve mood, ease anxiety, and dampen pain signals. It is a much weaker blocker of dopamine and does not inhibit monoamine oxidase (MAO).

Duloxetine dosage

▾

Duloxetine delayed-release capsules are taken by mouth, usually once daily, with or without food. Some depression regimens split the dose into two daily doses. Capsules are generally swallowed whole. Drizalma Sprinkle may also be opened and sprinkled on applesauce or given through a nasogastric tube.

  • Missed dose: take it when you remember, unless it is almost time for the next dose.
  • Never double up.
  • To stop, lower the dose gradually with your prescriber.

Follow your prescriber and the label for your exact dose.

Dosing details from the FDA-approved label

From the Duloxetine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Major Depressive Disorder (MDD) in adults
    • Starting dosage 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily)
    • For some patients, may start at 30 mg once daily for 1 week before increasing to 60 mg once daily
    • Maintenance Treatment: 60 mg/day
    • Maximum: 120 mg/day
    • No evidence that doses greater than 60 mg/day confer additional benefit
  • Generalized Anxiety Disorder (GAD) in adults less than 65 years of age
    • Initiate 60 mg once daily
    • For some patients, may start at 30 mg once daily for 1 week before increasing to 60 mg once daily
    • If increasing beyond 60 mg once daily, increase in increments of 30 mg once daily
    • Maximum: 120 mg/day
    • No evidence that doses greater than 60 mg/day confer additional benefit
  • GAD in geriatric patients
    • Initiate 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg/day
    • If increasing beyond 60 mg once daily, increase in increments of 30 mg once daily
    • Maximum: 120 mg/day (maximum dose studied)
  • GAD in pediatric patients 7 to 17 years of age
    • Initiate 30 mg once daily for 2 weeks before considering an increase to 60 mg once daily
    • Recommended dosage range is 30 to 60 mg once daily
    • If increasing beyond 60 mg once daily, increase in increments of 30 mg once daily
    • Maximum: 120 mg/day (maximum dose studied)
  • Diabetic Peripheral Neuropathic Pain (DPNP) in adults
    • 60 mg once daily
    • Maximum: 60 mg/day
    • For tolerability concerns a lower starting dose may be considered; consider a lower starting dosage and gradual increase for patients with renal impairment
  • Fibromyalgia (FM) in adults
    • Begin at 30 mg once daily for 1 week, then increase to 60 mg once daily
    • Some patients may respond to the starting dosage
    • Maximum: 60 mg/day
  • Chronic Musculoskeletal Pain in adults
    • Begin at 30 mg once daily for one week, then increase to 60 mg once daily
    • Maximum: 60 mg/day
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, chew or open capsule (2.1) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.3) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) 30 mg/day 60 mg/day (once daily) 60 mg/day • Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms (2.8, 5.7) 2.1 Important Administration Instructions Administer duloxetine delayed-release capsules orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time. 2.2 Dosage for Treatment of Major Depressive Disorder in Adults The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to duloxetine delayed-release capsules before increasng to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. Periodically reassess to determine the need for maintenance treatment and the appropriate dosage for such treatment. 2.3 Dosage for Treatment of Generalized Anxiety Disorder Recommended Dosage in Adults Less than 65 Years of Age For most adults less than 65 years of age with GAD, initiate duloxetine delayed-release capsules 60 mg once daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Duloxetine side effects

▾

The most common side effects in adult studies were:

Common side effects

  • Nausea
  • Dry mouth
  • Sleepiness (somnolence)
  • Constipation
  • Decreased appetite
  • Increased sweating (hyperhidrosis)
  • Headache
  • Dizziness
  • Fatigue
  • Insomnia

When to get medical help

  • Call right away if you have new or worsening depression, suicidal thoughts, agitation, panic attacks, or unusual changes in behavior.
  • Get help for yellowing of the skin or eyes (jaundice), belly pain, or other signs of liver problems.
  • Seek urgent care for possible serotonin syndrome: agitation, hallucinations, fast heartbeat, fever, heavy sweating, muscle stiffness or twitching, trouble with coordination, seizures, nausea, vomiting, or diarrhea.
  • Stop and get help for blisters, a peeling rash, sores in the mouth or other signs of a severe skin reaction.
  • Tell your doctor if you have fainting, dizziness when standing, or falls.
  • Report unusual bleeding or bruising.
  • Report symptoms of mania, such as unusually high energy or racing thoughts.
  • Report seizures, eye pain or vision changes (angle-closure glaucoma), or trouble urinating.

In children, common effects included decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea. Seek help for suicidal thoughts, liver problems, serotonin syndrome, severe skin reactions, fainting, or unusual bleeding.

Duloxetine warnings and precautions

▾
  • Suicidal thoughts and behavior in children, teens, and young adults (boxed warning).
  • Liver injury: hepatic failure, sometimes fatal, has been reported. Avoid with substantial alcohol use or chronic liver disease.
  • Low blood pressure on standing, falls, and fainting, especially early on or after dose increases.
  • Serotonin syndrome, particularly with other serotonergic drugs.
  • Bleeding risk, higher with NSAIDs, aspirin, or blood thinners.
  • Severe skin reactions, including Stevens-Johnson syndrome.
  • Mania, angle-closure glaucoma, seizures, higher blood pressure, low sodium, sexual problems, and urinary hesitation or retention.

Duloxetine interactions

▾

Duloxetine is processed by the liver enzymes CYP1A2 and CYP2D6, so some drugs change its levels. It can also affect other drugs.

  • MAOIs, linezolid, and IV methylene blue: contraindicated because of serotonin syndrome.
  • Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, St. John’s Wort and others): raise serotonin syndrome risk.
  • Fluvoxamine, cimetidine, ciprofloxacin: raise duloxetine levels and should be avoided.
  • Paroxetine, fluoxetine, quinidine: can raise duloxetine levels.
  • Thioridazine: avoid combining.
  • NSAIDs, aspirin, warfarin: higher bleeding risk.
  • Alcohol: possible liver injury risk with heavy use.
  • Duloxetine can raise levels of some drugs processed by CYP2D6, such as desipramine.

Interactions listed in the FDA-approved label

From the Duloxetine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of CYP1A2 (fluvoxamine, cimetidine, quinolone antimicrobials such as ciprofloxacin and enoxacin): Duloxetine 60 mg with fluvoxamine 100 mg increased duloxetine AUC approximately 6-fold, Cmax about 2.5-fold, and t1/2 approximately 3-fold. Potent inhibitors of CYP1A2 should be avoided.
  • Inhibitors of CYP2D6 (paroxetine, fluoxetine, quinidine): Duloxetine 40 mg once daily with paroxetine 20 mg once daily increased duloxetine AUC by about 60%; greater inhibition is expected with higher paroxetine doses.
  • Drugs that interfere with hemostasis (NSAIDs, aspirin, warfarin): Concurrent use of an NSAID or aspirin may potentiate the risk of bleeding; altered anticoagulant effects, including increased bleeding, have been reported with SSRIs or SNRIs and warfarin. Patients receiving warfarin should be carefully monitored when duloxetine is initiated or discontinued.
  • Lorazepam: Duloxetine pharmacokinetics were not affected by co-administration.
  • Temazepam: Duloxetine pharmacokinetics were not affected by co-administration.
  • Drugs that affect gastric acidity (antacids, famotidine, proton pump inhibitors): Aluminum- and magnesium-containing antacids or famotidine had no significant effect on duloxetine absorption; it is unknown whether proton pump inhibitors affect absorption. Caution in patients with conditions that may slow gastric emptying.
  • Drugs metabolized by CYP1A2 (theophylline, caffeine): Duloxetine inhibits CYP1A2; theophylline AUC increased 7% and 20% in two clinical studies with duloxetine 60 mg twice daily.
  • Drugs metabolized by CYP2D6 (desipramine): Duloxetine is a moderate CYP2D6 inhibitor; desipramine AUC increased 3-fold with duloxetine 60 mg twice daily.
  • Alcohol: Duloxetine did not increase the impairment of mental and motor skills caused by alcohol; liver injury occurred in three patients with substantial intercurrent ethanol use.
  • Drugs highly bound to plasma protein: Duloxetine may cause increased free concentrations of another highly protein-bound drug, potentially resulting in adverse reactions; warfarin showed no significant changes in INR or pharmacokinetics.
Read the label’s full interactions text

7 DRUG INTERACTIONS Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided (7.1) Potent inhibitors of CYP2D6 may increase duloxetine delayed-release capsules concentrations (7.2) Duloxetine delayed-release capsules are a moderate inhibitor of CYP2D6 (7.9) 7.1 Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions (5.12) ] . 7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12) ] . 7.3 Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of duloxetine 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and C max . 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿132 supplements and herbs with documented Duloxetine interactions, ranked by severity Check Duloxetine against a supplement or herb →

Before taking Duloxetine

▾
  • Do not use with or within 14 days of an MAOI.
  • Tell your prescriber about any history of bipolar disorder, mania, seizures, glaucoma, or high blood pressure.
  • Avoid with chronic liver disease, cirrhosis, or substantial alcohol use.
  • Avoid in severe kidney impairment.
  • Pregnancy: third-trimester use may cause newborn problems such as breathing trouble, feeding difficulty, and irritability.
  • Children and young adults need close monitoring for mood changes.
  • Older adults may be more likely to fall.

Duloxetine overdose

▾

Overdose can cause sleepiness, coma, serotonin syndrome, seizures, fainting, fast heartbeat, blood pressure changes, and vomiting. Deaths have been reported. There is no specific antidote, and treatment focuses on supportive care. Call Poison Control at 1-800-222-1222 or seek emergency help right away.

What Duloxetine does in the body

▾

Duloxetine strongly blocks serotonin and norepinephrine reuptake and blocks dopamine reuptake less. It has little effect on many other receptors and does not inhibit MAO. It belongs to a class of drugs known to affect urethral resistance. In a heart study at high doses, it did not prolong the QT interval.

How your body processes Duloxetine

▾

Duloxetine is well absorbed after a delayed start of about 2 hours, and levels peak several hours after a dose. Food can delay the peak but does not meaningfully change how much is absorbed. It is highly protein bound and broken down extensively by the liver through CYP1A2 and CYP2D6. Steady levels are reached in about 3 days.

How to store Duloxetine

▾

Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Dispense in tightly closed container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

132

Supplements & herbs that interact with Duloxetine

132 supplements and herbal products have documented interactions with Duloxetine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 107
  • Minor · 20
ACTIVATED CHARCOAL Major BEER Major LITHIUM Major SIBERIAN COCKLEBUR Major WINE Major 1,3-DMAA Moderate 5-HTP Moderate ACACIA RIGIDULA Moderate +124 more
Every supplement checked against Duloxetine — ranked by severity The full interaction hub: 5 major · 107 moderate · 20 minor · every one linked to its full report. Check Duloxetine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Duloxetine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

SODIUM Moderate Depletion
See the full Duloxetine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Duloxetine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Duloxetine — the kind of thing our pharmacy team would talk through with you at the counter.

What is duloxetine used for?

▾
It treats major depressive disorder and generalized anxiety disorder. It is also used for diabetic nerve pain, fibromyalgia, and chronic musculoskeletal pain such as low back or osteoarthritis pain. Which uses apply can depend on the product and your age, so check with me or your prescriber.

How should I take it?

▾
Take it by mouth, usually once a day, with or without food. Swallow the capsule whole and don’t crush, chew, or open it, unless you have Drizalma Sprinkle, which can be opened over applesauce. If you miss a dose, take it when you remember, but skip it if the next dose is near. Never double up.

What side effects should I expect?

▾
Nausea, dry mouth, sleepiness, constipation, less appetite, and sweating are the most common. Headache and dizziness also occur. Call your doctor for yellow skin or eyes, a blistering rash, unusual bleeding, fainting, or serotonin syndrome signs like agitation, fever, and muscle twitching.

Can I stop it if I feel better?

▾
Please don’t stop suddenly. Stopping abruptly can cause discontinuation symptoms, so your prescriber will lower the dose gradually. Check in with them before making any change.

Are there medicines or drinks I should avoid?

▾
Never combine it with MAOIs, linezolid, or IV methylene blue. Be careful with other serotonin-boosting drugs, NSAIDs, aspirin, and warfarin. Heavy alcohol use is a concern because of liver risk, so tell me about everything you take.

Do I need to watch my mood?

▾
Yes, especially in the first few months and when your dose changes. Young people up to age 24 have a higher risk of suicidal thoughts on antidepressants. Call your prescriber right away about new or worsening depression, agitation, or unusual behavior.

Is Duloxetine available over the counter?

▾
No. Duloxetine is a prescription medicine: every Duloxetine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Duloxetine first available?

▾
The earliest FDA record we hold for Duloxetine is from 2004: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Duloxetine was first used.

Who makes Duloxetine?

▾
41 companies currently list Duloxetine products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Proficient Rx LP. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Duloxetine on HelloPharmacist

📊Duloxetine supplement interactions132 checked — ranked by severity 🌿Drug & Supplement CheckerDuloxetine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Duloxetine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Duloxetine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Duloxetine forms and strengths (how it comes)

Duloxetine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Duloxetine inactive ingredients by manufacturer.

Delayed-release capsule

By mouth
Brands Cymbalta Drizalma Sprinkle Na
How this form is used
What it may be used for
  • Cymbalta is used for major depressive disorder and generalized anxiety disorder in adults, and generalized anxiety disorder in children 7 and older.
  • Cymbalta is also used for diabetic nerve pain, chronic musculoskeletal pain, and fibromyalgia in adults and in teens 13 and older.
  • Drizalma Sprinkle is used for fibromyalgia in adults, along with its other approved uses.
Important instructions
  • Cymbalta is taken once daily with or without food and swallowed whole, not crushed, chewed, or opened.
  • Drizalma Sprinkle can be swallowed whole, opened and sprinkled over applesauce, or given through a nasogastric tube.
  • Drizalma Sprinkle may be taken with or without food.
Available strengths 7 strengths
20 mg 30 mg 40 mg 60 mg 80 mg 90 mg
Show 1 more strength Show fewer strengths
120 mg
441 FDA-listed product records ⓘ

Duloxetine on the U.S. market: products, makers and brands

How Duloxetine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

41 companies list 203 Duloxetine product records with the FDA, mostly as delayed-release capsule; the earliest marketing or approval year on record is 2004. Brand names on the directory include Cymbalta, Drizalma Sprinkle, Irenka and 2 more; the rest are generics.

1
Dose forms ⓘ
41
Labelers (makers, repackagers, distributors)
9
Brand names
203
FDA-listed product records ⓘ
2004
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack12%
A-S Medication Solutions5%
Proficient Rx LP5%
Aphena Pharma Solutions - Tennessee, LLC4%
Remedyrepack Inc.4%
Asclemed USA, Inc.4%
Other makers64%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Duloxetine is used (Medicaid data)

A general measure of how commonly Duloxetine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Duloxetine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,105,865
Medicaid prescriptions filled (Q1–Q4 2025)
$63.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Duloxetine prescribed? Of the 1,601 medications we measure, Duloxetine ranks #50 by Medicaid prescriptions — more than 97% of them.

Where Duloxetine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #50 of 1,601
#45 Diclofenac Topical (ac... 4,673,607 Rx #46 Diclofenac 4,673,607 Rx #47 Lamotrigine 4,467,083 Rx #48 Cyclobenzaprine 4,437,147 Rx #49 Triamcinolone Topical 4,329,207 Rx #50 Duloxetine 4,105,865 Rx #51 Methadone 4,056,849 Rx #52 Guanfacine 4,043,576 Rx #53 Lisdexamfetamine 3,941,773 Rx #54 Cephalexin 3,933,834 Rx #55 Rosuvastatin 3,856,155 Rx

Utilization by Duloxetine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 60 mg delayed release oral capsule is the most-dispensed Duloxetine product — about 50% of these Medicaid prescriptions.

duloxetine 60 MG Delayed Release Oral Capsule Most dispensed

2,065,471 Medicaid prescriptions (Q1–Q4 2025) 50% of Duloxetine prescriptions shown $29.3M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 23 of 302 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 596934

duloxetine 30 MG Delayed Release Oral Capsule

1,449,344 Medicaid prescriptions (Q1–Q4 2025) 35% of Duloxetine prescriptions shown $19M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 22 of 331 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 596930

duloxetine 20 MG Delayed Release Oral Capsule

495,687 Medicaid prescriptions (Q1–Q4 2025) 12% of Duloxetine prescriptions shown $7.1M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 13 of 217 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 596926

duloxetine 40 MG Delayed Release Oral Capsule

89,532 Medicaid prescriptions (Q1–Q4 2025) 2% of Duloxetine prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 6 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616402

Sprinkle duloxetine 60 MG Delayed Release Oral Capsule

2,473 Medicaid prescriptions (Q1–Q4 2025) <1% of Duloxetine prescriptions shown $576,516 gross reimbursement (before rebates) ≈ $233 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2200181

Sprinkle duloxetine 30 MG Delayed Release Oral Capsule

2,294 Medicaid prescriptions (Q1–Q4 2025) <1% of Duloxetine prescriptions shown $566,886 gross reimbursement (before rebates) ≈ $247 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2200175

Sprinkle duloxetine 20 MG Delayed Release Oral Capsule

731 Medicaid prescriptions (Q1–Q4 2025) <1% of Duloxetine prescriptions shown $196,383 gross reimbursement (before rebates) ≈ $269 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2200168

Sprinkle duloxetine 40 MG Delayed Release Oral Capsule

333 Medicaid prescriptions (Q1–Q4 2025) <1% of Duloxetine prescriptions shown $78,108 gross reimbursement (before rebates) ≈ $235 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2200178

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Duloxetine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 68 of 906 listed Duloxetine NDCs with Medicaid activity.

Compare Duloxetine products

A representative set of FDA-listed product records for Duloxetine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 203 products — FDA National Drug Code Directory. See every product, package size and price: browse all 203 Duloxetine NDCs →

Duloxetine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Duloxetine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Duloxetine are nausea, fatigue, headache; about 62% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

186,795
Reports mentioning it
62%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
17,923
Fatigue
15,983
Headache
13,689
Dizziness
13,379
Pain
12,375
Diarrhoea
10,019
Insomnia
9,796
Anxiety
9,677
Vomiting
8,511
Depression
8,343
Age groups
Adult · 15,017Elderly · 8,172Neonate · 196Adolescent · 162Infant · 53Child · 21

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Duloxetine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Duloxetine FDA approval history

How Duloxetine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Duloxetine was first approved by the FDA in 2004 (Brand: CYMBALTA · Lilly); the first generic version was approved in 2013. It remains available in U.S. pharmacies today.

2004
Brand approved
Brand: CYMBALTA · Lilly
2013
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Duloxetine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 17 Duloxetine recalls since July 2021, covering 27 product listings. 15 of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jun 4, 2026 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcel… Lots: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. FDA record D-0583-2026 →
  • Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmac… Lots: Lot: 241180C, Exp. Date April 2027. FDA record D-0582-2026 →
Ongoing Class II May 14, 2026 · Asclemed USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
  • Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. Lots: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 FDA record D-0555-2026 →
Ongoing Class II Apr 29, 2026 · Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
  • Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. Lots: Lot#: PA10734, Exp. Jun 2026. FDA record D-0516-2026 →
  • Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 Lots: Lot#: PA07434, Exp. May 2026. FDA record D-0515-2026 →
  • Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridg… Lots: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. FDA record D-0514-2026 →
Ongoing Class II Apr 21, 2026 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
  • Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely… Lots: Lot: 241069C, Exp 05/31/2027 FDA record D-0522-2026 →
Ongoing Class II Nov 24, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharma… Lots: Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027. FDA record D-0216-2026 →
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharma… Lots: Lot #: 240947C, 240962C, Exp. Date 04/2027 FDA record D-0215-2026 →
Ongoing Class II Oct 9, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc… Lots: 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026 FDA record D-0100-2026 →
Ongoing Class II Aug 8, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
  • Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pha… Lots: Lot 240927C, Exp 04/30/2027 FDA record D-0621-2025 →
Ongoing Class II Jul 25, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pha… Lots: Lot 240539C, Exp 1/31/2027 FDA record D-0580-2025 →
Ongoing Class II Jul 15, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
  • Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals,… Lots: Lot: 230836C, Exp.: 02/28/2026 FDA record D-0552-2025 →
Ongoing Class II Jun 30, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Ber… Lots: Lot # 230199, Exp. Date 01/31/2026 FDA record D-0511-2025 →
Ongoing Class II Apr 14, 2025 · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
  • Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distribu… Lots: Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026 FDA record D-0388-2025 →
  • Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07… Lots: Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027 FDA record D-0387-2025 →
Ongoing Class II Mar 26, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
  • Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge P… Lots: Lot 240909C, Exp Date 03/31/2027 FDA record D-0308-2025 →
Ongoing Class II Feb 28, 2025 · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be… Lots: Lot#: 240098C, Expiration: 01/2027. FDA record D-0271-2025 →
  • Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., B… Lots: Lot#: 240225C, Expiration: 01/2027 FDA record D-0270-2025 →
  • Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., B… Lots: Lot#: 240301C, Expiration: 01/2027. FDA record D-0269-2025 →
Ongoing Class II Dec 6, 2024 · Breckenridge Pharmaceutical, Inc
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmac… Lots: Lot # 230077C, exp. date 11/2025 FDA record D-0162-2025 →
  • Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmace… Lots: Lot # 222205C, exp. date 11/2025 FDA record D-0161-2025 →
Ongoing Class II Apr 29, 2024 · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be… Lots: 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025 FDA record D-0484-2024 →
  • Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc.,… Lots: 220456: Exp. Feb 2025 FDA record D-0483-2024 →
  • Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Ba… Lots: 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025 FDA record D-0482-2024 →
Class II Oct 10, 2024 · Completed · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05. Lots: Lot #: 220128, Exp. Date 12/2024 FDA record D-0009-2025 →
Class II May 17, 2024 · Terminated · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berk… Lots: Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025 FDA record D-0562-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Duloxetine RxCUI 72625 1 dose form · 11 strengths

Look up RxCUI 72625 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Duloxetine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule, Delayed Release · Oral 30 mg $8.97 per capsule NDC details & price history
Capsule, Delayed Release · Oral 60 mg $8.97 per capsule NDC details & price history
Capsule, Delayed Release · Oral 20 mg $7.98 per capsule NDC details & price history
Capsule, Delayed Release · Oral 40 mg $1.24 per capsule NDC details & price history
Capsule, Delayed Release Pellets · Oral 60 mg $0.135 per capsule NDC details & price history
Capsule, Delayed Release Pellets · Oral 30 mg $0.102 per capsule NDC details & price history
Capsule, Delayed Release Pellets · Oral 20 mg $0.119 per capsule NDC details & price history
Capsule, Delayed Release Pellets · Oral 40 mg $1.24 per capsule NDC details & price history
Capsule, Delayed Release Pellets 60 mg $0.135 per capsule NDC details & price history
Capsule, Delayed Release Pellets 30 mg $0.102 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Duloxetine brand names

Duloxetine is sold under 5 brand names in the FDA directory — Cymbalta, Drizalma Sprinkle, Irenka, Drizalma and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cymbalta Drizalma Sprinkle Irenka Drizalma Na

Who makes Duloxetine: manufacturers and labelers

41 companies list Duloxetine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 25 A-S Medication Solutions 11 Proficient Rx LP 11 Aphena Pharma Solutions - Tennessee, LLC 9 Remedyrepack Inc. 9 Asclemed USA, Inc. 8 Preferred Pharmaceuticals Inc. 8 Quallent Pharmaceuticals Health LLC 8 Golden State Medical Supply, Inc. 7 Hawaii Repack, Inc. 7 Sun Pharmaceutical Industries, Inc. 7 NuCare Pharmaceuticals, Inc. 6 Advanced Rx of Tennessee, LLC 5 BluePoint Laboratories 5 Ajanta Pharma USA Inc. 4 Breckenridge Pharmaceutical, Inc. 4 Lupin Pharmaceuticals, Inc. 4 ANI Pharmaceuticals, Inc. 3 Actavis Pharma, Inc. 3 Advanced Rx Pharmacy of Tennessee, LLC 3 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 Almatica Pharma LLC 3 Ascend Laboratories, LLC 3

…and 17 more on the FDA NDC directory.

Duloxetine drug class (RxNorm)

Duloxetine belongs to the Serotonin and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Duloxetine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 14, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Duloxetine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Duloxetine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
141
Finished products in the current FDA directory
203
Companies listing them (makers, repackagers, distributors)
41
FDA labeler codes behind them ⓘ
44
Linked representative label ⓘ
Sun Pharmaceutical Industries, Inc.
Linked label effective
May 14, 2024
Composite sections available
27
Linked SPL Set ID
b41423b8-dfec-4d79-ba3c-e43a87803d85
Linked SPL Document ID
67134e3c-1819-4262-a36f-460afdbb165d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →