Atomoxetine
Atomoxetine is a non-stimulant medicine (a selective norepinephrine reuptake inhibitor) used to treat attention-deficit/hyperactivity disorder (ADHD), and it is available as capsules and an oral solution.
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 52 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 →
Atomoxetine (Strattera) is a non-stimulant ADHD medicine for adults and children 6 and older that blocks the recycling of norepinephrine, a brain messenger, and it is usually chosen when stimulants do not suit someone, in use since about 2002 and available generically. Most people tolerate it fairly well, though nausea, lower appetite and sleepiness are common at first, plus dry mouth or slow urination in adults. It carries a boxed warning for suicidal thoughts in children and teens, so watch mood and behavior closely early on and report yellowing skin, dark urine or chest pain. It builds up over several weeks, unlike a stimulant, so give it time.
Clinical pearls
- Paroxetine and fluoxetine can raise atomoxetine levels a lot, so tell any prescriber adding an antidepressant that you take it.
- Swallow capsules whole without opening them; the oral solution, measured only with its own syringe, suits those who cannot swallow capsules.
- If nausea or sleepiness bothers you, taking it with food or splitting it into morning and late-afternoon doses often helps.
- Expect blood pressure and pulse checks after dose increases, and regular height and weight checks for children.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Atomoxetine increased the risk of suicidal thoughts in children and teens with ADHD in short-term studies. About 0.4% (5 of 1,357) of those taking it had suicidal thoughts, compared with none on placebo. No suicides occurred in these trials.
The risk showed up early in treatment. Anyone starting it should be watched closely for suicidal thinking or behavior, worsening of symptoms, or unusual changes in behavior. Families and caregivers should stay in close contact with the prescriber. Atomoxetine is approved for ADHD in children and adults, but not for major depressive disorder.
Patient Information Guide A plain-language walkthrough of Atomoxetine, written from its FDA label.
What Atomoxetine Is Used For
▾
Atomoxetine is used to treat ADHD across its supported products.
- Strattera capsules: ADHD in adults and children 6 years and older.
- Atoncy oral solution: ADHD in adults and children 6 years and older.
- Atomoxetine hydrochloride oral solution: ADHD in adults and children 6 years and older.
- Atomoxetine capsules (generic): ADHD, as part of a total treatment program that may include psychological, educational and social measures.
How Atomoxetine Works
▾
Atomoxetine is a selective norepinephrine reuptake inhibitor. It is thought to block the norepinephrine transporter, which normally pulls norepinephrine back into nerve cells.
The exact way this helps ADHD symptoms is not known.
Atomoxetine Dosage
▾
Atomoxetine is taken by mouth as a capsule or an oral solution. Doses are given once daily in the morning or split into two evenly divided doses in the morning and late afternoon or early evening. Doses start low and are raised gradually, and children's doses are based on body weight.
- Capsules (Strattera and generics): take with or without food, and swallow whole without opening.
- Oral solution (Atoncy and atomoxetine hydrochloride): take with or without food, and use only the supplied syringe and bottle adapter.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Atomoxetine 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.
- Pediatrics who weigh less than 70 kg (ADHD)
- Starting 0.5 mg/kg/day
- Minimum of 3 days titration interval
- Target 1.2 mg/kg/day, administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening
- Maximum: 1.4 mg/kg/day or 100 mg/day, whichever is less
- No additional benefit demonstrated above 1.2 mg/kg/day; may be taken with or without food
- Pediatrics who weigh 70 kg or more and adults (ADHD)
- Starting 40 mg/day
- Minimum of 3 days titration interval
- Target 80 mg/day, administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening
- Maximum: 100 mg/day
- If optimal response not achieved at 80 mg/day after 2 to 4 additional weeks, may increase to a maximum of 100 mg/day
- Severe hepatic impairment (Child-Pugh Class C), patients 6 years or older
- Initial and target dosage is 25% of recommended dosage in patients with normal hepatic function
- Hepatic impairment adjustment
- Moderate hepatic impairment (Child-Pugh Class B), patients 6 years or older
- Initial and target dosage is 50% of the recommended dosage in patients with normal hepatic function
- Hepatic impairment adjustment
- Mild hepatic impairment (Child-Pugh Class A), patients 6 years or older
- Initial and target dosage is the same as those with normal hepatic function
- Pediatrics under 70 kg with a strong CYP2D6 inhibitor or CYP2D6 poor metabolizers
- Starting 0.5 mg/kg/day
- Titrate every 4 weeks if ADHD symptoms fail to improve and initial dosage is well tolerated
- Target 1.2 mg/kg/day
- Maximum: Maximum dosage has not been established
- Titration interval 4 weeks
- Pediatrics 70 kg or more and adults with a strong CYP2D6 inhibitor or CYP2D6 poor metabolizers
- Starting 40 mg/day
- Titrate every 4 weeks if ADHD symptoms fail to improve and initial dosage is well tolerated
- Target 80 mg/day
- Maximum: Maximum dosage has not been established
- Titration interval 4 weeks
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) Consider genetic testing to determine the patient’s CYP2D6 metabolizer status prior to dosing. ( 2.1 , 2.5 ) See table below for the recommended atomoxetine oral solution dosage. ( 2.3 ) Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. ( 2.4 ) For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information. ( 2.5 ) 2.1 Recommendations Prior to Initiating Atomoxetine Oral Solution Treatment Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6) ] . Consider genetic testing to determine the patient’s CYP2D6 metabolizer status [see Dosage and Administration (2.5) ] . 2.2 Administration Instructions Atomoxetine oral solution may be taken with or without food. Instruct patients to only use the supplied syringe and bottle adapter to measure and take atomoxetine oral solution [see Instructions for Use ] . 2.3 Recommended Dosage Table 1 includes the recommended dosage of atomoxetine oral solution in adult patients and pediatric patients 6 years of age and older for treatment of ADHD.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Atomoxetine Side Effects
▾
Side effects differ a bit between children and adults.
Common side effects
- Nausea and vomiting
- Decreased appetite
- Stomach pain
- Tiredness or sleepiness
- Headache
- Dizziness
- Dry mouth and constipation (mainly in adults)
- Erectile dysfunction and trouble starting urination (mainly in adults)
- Children: nausea, vomiting, tiredness, decreased appetite, stomach pain, sleepiness, headache, irritability and dizziness.
When to get medical help
- Call your doctor right away if a child or teen has new or worsening suicidal thoughts, agitation, irritability, panic, aggression or other unusual behavior changes.
- Get help for yellowing skin or eyes, dark urine, itching, pain in the upper right belly, or unexplained flu-like symptoms. These can be signs of liver injury.
- Seek care promptly for chest pain with exertion, fainting, or other heart symptoms.
- Tell your doctor if you see or hear things that are not there, develop odd beliefs, or have manic symptoms.
- Get urgent medical attention for an erection that will not go away (priapism).
- Stop and call for help if you have signs of an allergic reaction, such as rash, hives or swelling.
- Tell your doctor about trouble urinating or being unable to urinate.
Call your doctor promptly for mood or behavior changes, signs of liver injury, heart symptoms, a prolonged erection, or allergic reactions.
Atomoxetine Warnings and Precautions
▾
- Suicidal thoughts in children and teens (boxed warning): watch closely, especially early in treatment and at dose changes.
- Severe liver injury: rare cases, including liver failure. Stop atomoxetine and do not restart it if jaundice or lab evidence of liver injury appears.
- Heart risks: sudden death, stroke and heart attack have been reported. Heart history should be reviewed before starting.
- Blood pressure and heart rate: can rise, and dizziness on standing or fainting can occur. Pulse and blood pressure should be checked regularly.
- Psychiatric effects: new hallucinations, delusional thinking or mania can occur, and aggression or hostility should be monitored.
- Other: urinary hesitancy or retention, priapism, allergic reactions, and slowed growth, so children's height and weight should be monitored.
Atomoxetine Interactions
▾
Some medicines can change how atomoxetine works or affect your heart and blood pressure.
- MAOIs: dangerous, sometimes fatal reactions. Keep a 2-week gap.
- Paroxetine, fluoxetine, quinidine: block CYP2D6 and can raise atomoxetine levels several-fold.
- Blood pressure medicines and pressor agents: may affect blood pressure.
- Albuterol by mouth or injection: heart rate and blood pressure effects can be boosted.
- Alcohol and methylphenidate: no added effects were seen in the label's studies.
Interactions listed in the FDA-approved label
From the Atomoxetine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine oxidase inhibitors (MAOIs): Serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes including extreme agitation progressing to delirium and coma) have been reported with drugs affecting brain monoamines taken with an MAOI. Contraindicated; at least 14 days must elapse between stopping an MAOI and starting atomoxetine, and 14 days after stopping atomoxetine before starting an MAOI.
- CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): In extensive metabolizers they increase atomoxetine steady-state plasma concentrations to exposures similar to poor metabolizers; AUC is approximately 6 to 8 fold and Css,max about 3 to 4 fold greater with paroxetine or fluoxetine. See dosage recommendations for concomitant use of a strong CYP2D6 inhibitor.
- Antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure: Possible effects on blood pressure. Use cautiously.
- Albuterol (or other beta 2 agonists), systemic oral or intravenous: The action of albuterol on the cardiovascular system can be potentiated, resulting in increases in heart rate and blood pressure. Administer with caution.
- CYP3A substrates (e.g., midazolam): Atomoxetine did not cause clinically important inhibition or induction; midazolam AUC increased 15%. No dose adjustment is recommended for drugs metabolized by CYP3A.
- CYP2D6 substrates (e.g., desipramine): Did not alter the pharmacokinetics of desipramine. No dose adjustment is recommended for drugs metabolized by CYP2D6.
- Alcohol (ethanol): Consumption of ethanol with atomoxetine did not change the intoxicating effects of ethanol.
- Methylphenidate: Coadministration did not increase cardiovascular effects beyond those seen with methylphenidate alone.
- Drugs highly bound to plasma protein (warfarin, acetylsalicylic acid, phenytoin, diazepam): Atomoxetine did not affect the binding of these drugs to human albumin, and they did not affect binding of atomoxetine.
- Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole): Had no effect on atomoxetine bioavailability.
Read the label’s full interactions text
7 DRUG INTERACTIONS Monoamine Oxidase Inhibitors. ( 4.2 , 7.1 ) CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. ( 7.2 ) Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. ( 7.3 ) Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. ( 7.4 ) 7.1 Monoamine Oxidase Inhibitors With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity [ see Contraindications ( 4.2 ) ]. 7.2 Effect of CYP2D6 Inhibitors on Atomoxetine In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in poor metabolizers (PMs). In EM individuals treated with paroxetine or fluoxetine, the AUC of atomoxetine is approximately 6 to 8 fold and C ss, max is about 3 to 4 fold greater than atomoxetine alone. In vitro studies suggest that coadministration of cytochrome P450 inhibitors to PMs will not increase the plasma concentrations of atomoxetine. 7.3 Antihypertensive Drugs and Pressor Agents Because of possible effects on blood pressure, atomoxetine hydrochloride should be used cautiously with antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure.
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.
Before Taking Atomoxetine
▾
- Allergy to atomoxetine or its ingredients.
- Recent MAOI use, within 2 weeks.
- Narrow angle glaucoma.
- Pheochromocytoma or a history of it.
- Severe heart or blood vessel disorders.
- Personal or family history of bipolar disorder, mania or hypomania.
- Liver impairment: moderate or severe cases need a lower dose.
- Kidney disease: normal dosing can be used, including with end stage renal disease.
- Pregnancy and breastfeeding: discuss with your doctor, because human data are limited.
- Children under 6 and older adults: not evaluated.
Atomoxetine Overdose
▾
Overdose symptoms can include stomach upset, sleepiness, dizziness, tremor, abnormal behavior, hyperactivity and agitation. Seizures, fast heartbeat, higher blood pressure, dilated pupils, dry mouth, QT prolongation, and confusion or hallucinations have also been reported. Contact a Certified Poison Control Center for guidance.
What Atomoxetine Does in the Body
▾
Higher atomoxetine exposure was linked to greater improvement in ADHD symptom scores. A heart-rhythm study found no large QTc changes, but small ones could not be ruled out, and there was a slight QTc increase at higher levels. Atomoxetine can increase heart rate and blood pressure, and it boosted the heart rate and blood pressure effects of albuterol given by injection.
How Your Body Processes Atomoxetine
▾
Atomoxetine is mainly broken down by the CYP2D6 liver enzyme. Its half-life is about 5 hours in most people but about 22 hours in CYP2D6 poor metabolizers, who have higher levels in the body. Food lowers the peak level but does not change total exposure. Most of the dose leaves in urine as a metabolite, and very little leaves unchanged.
How to Store Atomoxetine
▾
Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & Herbs That Interact With Atomoxetine
77 supplements and herbal products have documented interactions with Atomoxetine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 56
- Minor · 20
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.
Atomoxetine: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Atomoxetine — the kind of thing our pharmacy team would talk through with you at the counter.
What is atomoxetine for?
▾
How should I take it?
▾
What side effects should I expect?
▾
What should I watch for in my child?
▾
Are there medicines I shouldn't combine with it?
▾
Are there liver or heart symptoms I should call about?
▾
Is Atomoxetine available over the counter?
▾
When was Atomoxetine first available?
▾
Who makes Atomoxetine?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Atomoxetine on HelloPharmacist
Atomoxetine Forms and Strengths (How It Comes)
Atomoxetine is available in 2 forms. 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 Atomoxetine inactive ingredients by manufacturer.
Capsule
How this form is used
- Strattera is used to treat ADHD in adults and children 6 years and older.
- Atomoxetine capsules are used to treat ADHD as part of a total treatment program.
- Strattera may be taken with or without food.
- Strattera capsules should be swallowed whole and not opened.
- Atomoxetine capsules may be taken with or without food and should be swallowed whole, not opened.
Show 1 more strength Show fewer strengths
Oral solution
How this form is used
- Atoncy is used to treat ADHD in adults and children 6 years and older.
- Atomoxetine hydrochloride oral solution is used to treat ADHD in adults and children 6 years and older.
- Atoncy may be taken with or without food.
- Atoncy should be measured and taken only with the supplied syringe and bottle adapter.
- Atomoxetine hydrochloride oral solution may be taken with or without food, using only the supplied syringe and bottle adapter.
Atomoxetine on the U.S. Market: Products, Makers and Brands
How Atomoxetine 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.
22 companies list 137 Atomoxetine product records with the FDA, mostly as capsule, oral solution; the earliest marketing or approval year on record is 2002. Brand names on the directory include Strattera, Atoncy; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (19) · Unfinished capsule (14) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How Widely Atomoxetine Is Used (Medicaid Data)
A general measure of how commonly Atomoxetine 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 Atomoxetine 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.
How commonly is Atomoxetine prescribed? Of the 1,603 medications we measure, Atomoxetine ranks #129 by Medicaid prescriptions — more than 92% of them.
Utilization by Atomoxetine 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.
atomoxetine 40 MG Oral Capsule Most dispensed
Summed across the 10 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349594
atomoxetine 25 MG Oral Capsule
Summed across the 9 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349593
atomoxetine 60 MG Oral Capsule
Summed across the 9 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349595
atomoxetine 18 MG Oral Capsule
Summed across the 9 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349592
atomoxetine 80 MG Oral Capsule
Summed across the 9 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 608143
atomoxetine 10 MG Oral Capsule
Summed across the 9 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349591
atomoxetine 100 MG Oral Capsule
Summed across the 9 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 608139
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 Atomoxetine, 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 64 of 329 listed Atomoxetine NDCs with Medicaid activity.
Compare Atomoxetine Products
A representative set of FDA-listed product records for Atomoxetine — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 25 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 40 mg | Oral | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 60 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 80 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 40 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 18 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 25 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 40 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 60 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 80 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 100 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 18 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 25 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 40 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 60 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 80 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | AvKARE | ANDA | View NDC → |
| 18 mg | Oral | AvKARE | ANDA | View NDC → |
| 25 mg | Oral | AvKARE | ANDA | View NDC → |
| 40 mg | Oral | AvKARE | ANDA | View NDC → |
| 60 mg | Oral | AvKARE | ANDA | View NDC → |
| 80 mg | Oral | AvKARE | ANDA | View NDC → |
| 100 mg | Oral | AvKARE | ANDA | View NDC → |
| 25 mg | Oral | AvPAK | ANDA | View NDC → |
| 40 mg | Oral | AvPAK | ANDA | View NDC → |
| 60 mg | Oral | AvPAK | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 18 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 60 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 80 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 18 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 18 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 25 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 40 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 60 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 80 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 100 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 18 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 25 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 40 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 60 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 80 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 100 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 10 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 18 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 25 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 40 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 60 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 80 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 100 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 10 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 18 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 25 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 40 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 60 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 80 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 100 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 18 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 10 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 18 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 18 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 25 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 25 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 40 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 40 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 60 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 60 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 80 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 80 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 100 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 100 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 10 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 100 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 18 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 18 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 25 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 40 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 60 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 80 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 100 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 10 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 18 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Oral solution | ||||
| 4 mg/mL | Oral | Advagen Pharma Ltd. | NDA AUTHORIZED GENERIC | View NDC → |
| 4 mg/mL | Oral | Validus Pharmaceuticals LLC | NDA | View NDC → |
Showing 137 of 137 products — FDA National Drug Code Directory. See every product, package size and price: browse all 137 Atomoxetine NDCs →
Atomoxetine 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 Atomoxetine — a signal of what to watch for, not proof the drug caused it.
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 Atomoxetine 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.
Atomoxetine FDA Approval History
How Atomoxetine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Atomoxetine 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 2 Atomoxetine recalls since July 2021, covering 15 product listings. Both are still ongoing or began in the last six months. 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.
- Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 Lots: Lot #: 25530722 FDA record D-0538-2026 →
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. Lots: Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026. FDA record D-0244-2025 →
- Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01. Lots: Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026. FDA record D-0243-2025 →
- Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. Lots: Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026. FDA record D-0242-2025 →
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. Lots: Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026. FDA record D-0241-2025 →
- Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. Lots: Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026. FDA record D-0240-2025 →
- Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. Lots: Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026. FDA record D-0239-2025 →
- Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. Lots: Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026. FDA record D-0238-2025 →
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. Lots: Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026. FDA record D-0237-2025 →
- and 6 more product listings in this recall (14 in all)
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 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.
RxCUI 38400 2 dose forms · 8 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 378308In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 2739830In current FDA listingsClinical drug / strength (SCD) 4 MG/MLRxCUI 2739831
Look up RxCUI 38400 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.
Atomoxetine Supply and Shortage Status
Whether Atomoxetine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Atomoxetine Costs Pharmacies (NADAC Benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Jul 15, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 40 mg | $13.65 per capsule | NDC details & price history |
| Capsule · Oral | 60 mg | $13.66 per capsule | NDC details & price history |
| Capsule · Oral | 25 mg | $12.57 per capsule | NDC details & price history |
| Capsule · Oral | 100 mg | $14.72 per capsule | NDC details & price history |
| Capsule · Oral | 10 mg | $12.66 per capsule | NDC details & price history |
| Capsule · Oral | 80 mg | $14.75 per capsule | NDC details & price history |
| Capsule · Oral | 18 mg | $12.64 per capsule | NDC details & 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.
Atomoxetine Brand Names
Atomoxetine is sold under 2 brand names in the FDA directory — Strattera, Atoncy. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Atomoxetine: Manufacturers and Labelers
22 companies list Atomoxetine products with the FDA. By number of product records, the largest are A-S Medication Solutions, NorthStar RxLLC, Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Atomoxetine Drug Class (RxNorm)
Atomoxetine belongs to the Norepinephrine Reuptake Inhibitor class.
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 Atomoxetine 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.
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. Northstar Rx LLC 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 →