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Atomoxetine Hydrochloride 10 mg Capsule, 30-count — NDC 70518-4313-00 package photo
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Atomoxetine Hydrochloride 10 mg Capsule, 30-count — NDC 70518-4313-0 (Billing 70518-4313-00)

by REMEDYREPACK INC. · 30 POUCH in 1 BOX / 1 CAPSULE in 1 POUCH

This is a package of 30 capsules of Atomoxetine Hydrochloride 10 mg Capsule from REMEDYREPACK INC., marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 70518-4313-00
🏷️ FDA NDC (as labeled) 70518-4313-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-4313-0
Product NDC 70518-4313
11-digit billing NDC 70518431300
RxCUI 349591
UNII 57WVB6I2W0
Application # ANDA078983
SPL Set ID 6d7ea8f7-981c-4acc-aeaf-7516325bfc0c
Established class (EPC) Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-19
Route ORAL
Dosage form CAPSULE
Substance ATOMOXETINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 349591
Why two NDCs? The FDA registers this code as 70518-4313-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-4313-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Norepinephrine Reuptake Inhibitor
Drug family (ATC) Centrally acting sympathomimetics
How it works Norepinephrine Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Atomoxetine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. Atomoxetine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats ADHD in adults and in children 6 and older. It's not a stimulant, and it works best as part of a full plan that can include behavioral, educational and social support.
  • Take it by mouth once a day in the morning, or split into two doses in the morning and late afternoon or early evening, as your prescriber directs. Food doesn't matter. Swallow cap...
  • In children, the most common are nausea, vomiting, tiredness, stomach pain, sleepiness and lower appetite. Adults more often notice dry mouth, constipation, dizziness, lower appeti...
  • Atomoxetine carries a boxed warning for suicidal thoughts in children and teens, mostly early in treatment. Watch daily for agitation, irritability, anxiety, aggression, panic or u...
📖 Read our full Atomoxetine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.8079 $24.24 / 30 capsule
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-4313-00 You're viewing this Main listing 30 POUCH in 1 BOX / 1 CAPSULE in 1 POUCH 2025-03-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atomoxetine 10 mg 00093-3542-56 Teva 30 capsules $0.322 AB Availability likely —
atomoxetine 10 mg 16714-0755-01 Northstar 30 capsules $0.322 AB Availability likely —
Atomoxetine 10 mg 31722-0714-30 Camber 30 capsules $0.322 AB Availability likely —
Atomoxetine Hydrochloride 10 mg 60505-2830-03 Apotex 30 capsules $0.322 AB Availability likely —
Atomoxetine 10 mg 64380-0472-01 Strides 30 capsules $0.322 AB Availability likely —
Atomoxetine 10 mg 64980-0373-03 Rising 30 capsules $0.322 AB Availability likely —
Atomoxetine 10 mg 72603-0435-01 NorthStar 30 capsules $0.322 AB Availability likely —
Strattera 10 mg 00002-3227-30 Eli 30 capsules $12.658 — Availability likely —
Atomoxetine 10 mg 42291-0064-30 AvKARE 30 capsules — AB FDA listed —
Atomoxetine Hydrochloride 10 mg 51407-0100-30 Golden 30 capsules — AB FDA listed —
Atomoxetine 10 mg 55111-0519-05 Dr. 500 capsules — AB FDA listed —
Atomoxetine 10 mg 65862-0238-22 Aurobindo 2000 capsules — AB FDA listed —
atomoxetine 10 mg 68462-0265-23 Glenmark 2000 capsules — AB FDA listed —
Atomoxetine Hydrochloride 10 mgthis 70518-4313-00 REMEDYREPACK 30 capsules — AB FDA listed —
Atomoxetine 10 mg 72162-2541-03 Bryant 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeCapsule
ImprintAPO;AM10
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderAPOTEX INC
FDA applicationANDA078983 (ANDA)
Labeler code70518
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio1,527 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All atomoxetine-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping atomoxetine capsules in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions (5.1)].

Atomoxetine capsules increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All atomoxetine-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes ( 5.1 ) Consider stopping atomoxetine capsules in patients who experience emergent suicidal thoughts and behavior ( 5.1 ) Atomoxetine capsules increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-­deficit/hyperactivity disorder (ADHD) in short-term studies ( 5.1 )

🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE Atomoxetine capsules are a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 ) Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with atomoxetine capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) See table below for the recommended atomoxetine capsule 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 )

2.1Recommendations Prior to Initiating Atomoxetine Capsules Treatment Prior to initiating treatment with atomoxetine capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )].

2.2Administration Instructions Atomoxetine capsules may be taken with or without food. Take atomoxetine capsules whole; do not open the capsules.

2.3Recommended Dosage Table 1 includes the recommended atomoxetine capsules dosage in adult patients and pediatric patients 6 years of age and older for acute treatment of ADHD. Table 1: Recommended Dosage of Atomoxetine Capsules for Acute Treatment of ADHD Age and Body Weight Starting Dosage Titration Interval Target Dosage Maximum Dosage Pediatric patients who weigh less than 70 kg 0.5 mg/kg/day Minimum of 3 days 1.2 mg/kg/day a,b 1.4 mg/kg/day or 100 mg/day, whichever is less a Pediatric patients who weigh 70 kg or more and adult patients 40 mg/day Minimum of 3 days 80 mg/day a 100 mg/day a,c a Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening. b No additional benefit has been demonstrated with atomoxetine capsules dosages higher than 1.2 mg/kg/day [see Clinical Studies ( 14 )]. c If a patient has not achieved an optimal response at 80 mg/day after 2 to 4 additional weeks, may increase the dosage to a maximum of 100 mg/day.

There is no data that supports increased effectiveness at a dosage higher than 100 mg/day [see Clinical Studies ( 14 )]. The health care provider who elects to use atomoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of atomoxetine capsules for the individual patient.

2.4Recommended Dosage in Patients with Hepatic Impairment For patients aged 6 years of age or older with: Severe hepatic impairment (HI) (Child-Pugh Class C), the recommended initial and target atomoxetine capsules dosage is 25% of recommended dosage in patients with normal hepatic function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. Moderate HI (Child-Pugh Class B), the recommended initial and target atomoxetine capsules dosage is 50% of the recommended dosage in patients with normal hepatic function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].

Mild HI (Child-Pugh Class A), the recommended initial and target atomoxetine capsules dosage is the same as those with normal hepatic function.

2.5Recommended Dosage with Concomitant Use of Strong CYP2D6 Inhibitors or in CYP2D6 Poor Metabolizers Consider genetic testing to determine the patient’s CYP2D6 metabolizer status. In patients taking a concomitant strong CYP2D6 inhibitor or who are CYP2D6 poor metabolizers, a longer titration interval of 4 weeks is recommended, if ADHD symptoms fail to improve and the initial atomoxetine capsules dosage is well tolerated. The recommended starting, target, and maximum atomoxetine capsules dosages are the same as outlined in Table 1 [see Dosage… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine hydrochloride, USP equivalent to: 10 mg of atomoxetine (Opaque White, Opaque White) Capsules: contain 10 mg of atomoxetine. ( 3 , 11 , 16 )

⛔ Contraindications 215 words ▾

4 CONTRAINDICATIONS Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of atomoxetine capsules. Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma With pheochromocytoma or history of pheochromocytoma With severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate Atomoxetine capsules are contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of atomoxetine capsules.

Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions ( 5.8 )]. Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions ( 7 )]. With narrow angle glaucoma.

In clinical trials, atomoxetine capsules use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received atomoxetine capsules.

With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had a clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions ( 5.4 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Severe Liver Injury: Atomoxetine capsules should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to atomoxetine capsules treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. Atomoxetine capsules generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias.

Consideration should be given to not using atomoxetine capsules in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during atomoxetine capsules treatment should stop atomoxetine capsules and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following atomoxetine dosage increase, and periodically while on therapy.

( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing atomoxetine capsules. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow: Urinary retention or hesitancy may occur.

( 5.9 ) Priapism: Prompt medical attention is required in the event of suspected priapism. ( 5.10 ) Effect on Growth in Pediatric Patients: Closely monitor growth (e.g., weight, height) in pediatric patients. ( 5.11 )

5.1Suicidal Thoughts and Behaviors in Pediatric Patients 6 Years of Age and Older All atomoxetine-treated pediatric patients should be monitored and observed closely for clinical worsening, suicidal thoughts and behavior, and unusual changes in behavior, especially during the initial few months of atomoxetine therapy, or at times of dosage changes, either increases or decreases. Families and caregivers of atomoxetine-treated pediatric patients should be alerted about the need to monitor patients daily for the emergence of agitation, irritability, unusual changes in behavior, and mental health-related symptoms, as well as the emergence of suicidal thoughts and behavior, and to report such symptoms immediately to a health care provider.

Consider changing the therapeutic regimen, including stopping atomoxetine capsules, in patients who experience emergent suicidality or symptoms that might be precursors to emerging suicidal thoughts and behavior, especially if these symptoms are severe or abrupt in onset, or were not part of the patient’s presenting symptoms. Atomoxetine capsules increased the risk of suicidal ideation in pediatric patients 6 years and older with ADHD in pooled placebo-controlled short-term studies (6 to 18 weeks). In 12 studies (11 studies in patients with ADHD and 1 study in another population) with over 2,200 pediatric patients, the mean incidence of suicidal ideation in atomoxetine-treated pediatric patients was 0.4% (5/1,357) (including one patient with a suicide attempt) compared to 0% (0/851) in placebo-treated pediatric patients.

No suicides occurred in these studies. All the suicidal ideations occurred in pediatric patients 6 to 12 years of age, and all occurred during the first month of atomoxetine capsules treatment. It is unknown whether the risk of suicidal ideation in pediatric patients extends to longer-term use.

A similar analysis in adult patients treated with atomoxetine capsules for ADHD did not reveal an increased risk of suicidal ideation or behavior. The following psychiatric symptoms have been reported with atomoxetine capsules: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that such symptoms may rep… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by atomoxetine capsules.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Atomoxetine was administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14.1 )] and 1,007 adults in clinical ADHD studies (Studies 6 and 7) [see Clinical Studies ( 14.2 )] .

In the ADHD clinical trials, 2,529 pediatric patients were treated for over 6 months which included 1,625 pediatric patients who were treated for longer than 1 year. Adverse Reactions in the Clinical Trials of Pediatric Patients 6 Years of Age and Older with ADHD Discontinuation of Treatment Due to Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: In the acute placebo-controlled studies of pediatric patients 6 years of age and older with ADHD, 3% (48/1,613) of atomoxetine-treated pediatric patients and 1.4% (13/945) of placebo-treated pediatric patients discontinued due to an adverse reaction.

Among atomoxetine-treated patients, irritability (0.3%, N=5); somnolence (0.3%, N=5); aggression (0.2%, N=4); nausea (0.2%, N=4); vomiting (0.2%, N=4); abdominal pain (0.2%, N=4); constipation (0.1%, N=2); fatigue (0.1%, N=2); feeling abnormal (0.1%, N=2); and headache (0.1%, N=2) were the reasons for discontinuation reported by more than one patient. For all studies, (including open-label and long-term studies), 6% of atomoxetine-treated pediatric patients who were other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and 11% of those who were CYP2D6 poor metabolizers discontinued due to an adverse reaction.

Common Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: Common adverse reactions (incidence of 2% or greater in atomoxetine-treated patients and with a higher incidence in atomoxetine-treated patients compared to placebo-treated patients) in pediatric patients 6 years of age and older with ADHD are listed in Table 2. The most commonly observed adverse reactions in atomoxetine-treated patients (incidence of ≥5% and ≥ twice the incidence in placebo-treated patients), for either twice daily or once daily dosing were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence (see Tables 2 and 3).

Table 2: Common Adverse Reactions a in Acute Studies (up to 18 weeks) in Pediatric Patients 6 Years and Older with ADHD Adverse Reaction Atomoxetine (N=1,597) Placebo (N=934) Headache 19% 15% Abdominal pain b 18% 10% Decreased appetite 16% 4% Somnolence c 11% 4% Vomiting 11% 6% Nausea 10% 5% Fatigue 8% 3% Irritability 6% 3% Dizziness 5% 2% Decreased weight 3% 0% Anorexia 3% 1% Rash 2% 1% a Adverse reactions reported by at least 2% of atomoxetine-treated patients and greater than placebo-treated patients. b Abdominal pain includes the terms: upper abdominal pain, and epigastric discomfort. c Somnolence includes the term sedation.

Adverse reaction in the atomoxetine-treated patients who received twice daily, and once daily dosing are shown in Table 3 (adverse reactions based on… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Monoamine Oxidase Inhibitors: Concomitant use contraindicated. ( 4 , 7 ) Strong CYP2D6 Inhibitors: With concomitant use of atomoxetine capsules and strong CYP2D6 inhibitors, increase the titration intervals. ( 7 ) Antihypertensives: Increase the frequency of monitoring blood pressure and adjust atomoxetine capsules dosage as clinically appropriate.

( 7 ) Albuterol (or other beta2 agonists): Increase the frequency of monitoring blood pressure and heart rate. ( 7 ) See Table 8 for clinically significant drug interactions with atomoxetine and other drugs. Table 8: Clinically Significant Drug Interactions with Atomoxetine and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Atomoxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days.

Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of atomoxetine and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of atomoxetine and a strong CYP2D6 inhibitor, increase the titration interval [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )].

Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate. The concomitant use of atomoxetine and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Clinical Pharmacology ( 12.3 )]. Antihypertensive Drugs Prevention or Management Increase the frequency of monitoring blood pressure and adjust atomoxetine dosage as clinically appropriate.

Mechanism and Clinical Effect(s) Because of increased risk of increased blood pressure, atomoxetine should be used cautiously with antihypertensive drugs, other drugs that increase blood pressure or pressor drugs (e.g., dopamine, dobutamine). Albuterol or Other Beta2 Agonists Prevention or Management Increase the frequency of monitoring blood pressure and heart rate and adjust atomoxetine dosage as clinically appropriate. Mechanism and Clinical Effect(s) Systemically administered albuterol (e.g., oral) can be potentiated by atomoxetine, resulting in increases in heart rate and blood pressure [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Increased exposure (AUC) to atomoxetine in subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) compared to subjects with normal liver function. ( 8.6 and 12.3 ) Use in Genomic Subgroups: CYP2D6 poor metabolizers have higher systemic exposures which may increase the risks of atomoxetine capsules-related adverse reactions compared to other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.

In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data: Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.

These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (other CYP2D6 metabolizer types) or 0.4 times (CYP2D6 poor metabolizers) those in humans receiving the MRHD.

Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).

In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the peri… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.

In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data: Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.

These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (other CYP2D6 metabolizer types) or 0.4 times (CYP2D6 poor metabolizers) those in humans receiving the MRHD.

Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).

In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis, a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at 40 mg/kg/day (approximately 5 times the MRHD on a mg/m 2 basis) but not at 20 mg/kg/day. No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (approximately 17 times the MRHD on a mg/m 2 basis) by gavage throughout the period of organogenesis.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of atomoxetine for the treatment of ADHD have been established in pediatric patients 6 years of age and older. Anyone considering the use of atomoxetine in a pediatric patient should balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.3 , 5.4 , 5.10 )]. The atomoxetine pharmacokinetics in pediatric patients 6 years of age and older were similar to those in adults.

The safety and effectiveness of atomoxetine in pediatric patients less than 6 years of age have not been established. Juvenile Toxicity Animal Data A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. Rats were treated with 1, 10, or 50 mg/kg/day (approximately 0.2, 2, and 8 times, respectively, the maximum human dose on a mg/m 2 basis) of atomoxetine given by gavage from the early postnatal period (Day 10 of age) through adulthood.

Slight delays in onset of vaginal patency (all doses) and preputial separation (10 and 50 mg/kg), slight decreases in epididymal weight and sperm number (10 and 50 mg/kg), and a slight decrease in corpora lutea (50 mg/kg) were seen, but there were no effects on fertility or reproductive performance. A slight delay in onset of incisor eruption was seen at 50 mg/kg. A slight increase in motor activity was seen on Day 15 (males at 10 and 50 mg/kg and females at 50 mg/kg) and on Day 30 (females at 50 mg/kg) but not on Day 60 of age.

There were no effects on learning and memory tests. The significance of these findings to humans is unknown.

🧓 Geriatric Use 44 words ▾

8.5Geriatric Use The safety, efficacy and pharmacokinetics of atomoxetine in geriatric patients have not been evaluated. Clinical studies of atomoxetine did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🆘 Overdosage 179 words ▾

10 OVERDOSAGE During postmarketing use, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine and at least one other drug. There have been no reports of death involving overdose of atomoxetine alone, including intentional overdoses at amounts up to 1,400 mg (14 times the maximum recommended dosage). The most commonly reported symptoms with acute and chronic overdoses of atomoxetine were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior.

Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate.

In some cases of overdose involving atomoxetine, seizures have been reported. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology ( 12.2 )]. If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of atomoxetine overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which atomoxetine produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

12.2Pharmacodynamics An exposure-response analysis of atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure correlates with efficacy as measured by the ADHD Rating Scale-IV-Parent Version: Investigator administered and scored. The exposure-efficacy relationship was similar to that observed between atomoxetine dosage and efficacy with median atomoxetine exposures at the two highest doses resulting in near maximal changes from baseline [see Clinical Studies ( 14.2 )]. Cardiac Electrophysiology The effect of atomoxetine on QTc interval prolongation was evaluated in a randomized, double-blinded, positive-(moxifloxacin 400 mg) and placebo-controlled, cross-over study in healthy male CYP2D6 poor metabolizers.

A total of 120 healthy subjects were administered atomoxetine (20 mg and 60 mg) twice daily for 7 days. No large changes in QTc interval (i.e., increases >60 msec from baseline, absolute QTc >480 msec) were observed in the study. However, small changes in QTc interval cannot be excluded from this study, because the study failed to demonstrate assay sensitivity.

There was a slight increase in QTc interval with increased atomoxetine concentration. Pharmacodynamic Drug Interaction Studies Consumption of ethanol with atomoxetine did not change the intoxicating effects of ethanol. Concomitant use of atomoxetine with methylphenidate did not increase cardiovascular effects beyond those seen with methylphenidate alone.

Albuterol 600 mcg given intravenously over 2 hours (albuterol is not approved for intravenous use) induced heart rate and blood pressure increases; these effects were potentiated when co-administered with atomoxetine (60 mg twice daily for 5 days), particularly initially [see Drug Interactions (7)].

12.3Pharmacokinetics Pharmacokinetic parameters for atomoxetine and its metabolites in CYP2D6 poor metabolizers and other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) are presented in Table 9. Table 9: Atomoxetine and Metabolite Pharmacokinetics in Adult CYP2D6 Poor Metabolizers and Other CYP2D6 Metabolizer Types Parameter Other CYP2D6 Metabolizer Types a CYP2D6 Poor Metabolizers b Absorption Dose proportionality 10 to 120 mg Accumulation 1.1-fold 3.3-fold Absolute bioavailability 63% 94% T max median 1 hour 2.5 hour Effect of Food AUC: Unchanged; C max : Decreased 37%; T max : Delayed 3 hours Distribution Protein Binding 98% Volume of distribution

0.85L/kg Elimination Atomoxetine half-life 5.2 hours 21.6 hours Atomoxetine apparent oral clearance

0.35 L/hr/kg

0.03L/hr/kg 4-Hydroxyatomoxetine half-life 6 to 8 hours -- N-Desmethylatomoxetine half-life 6 to 8 hours 34 to 40 hours Metabolism Primary metabolic pathways CYP2D6 Other CYP enzymes 4-Hydroxyatomoxetinec concentration 1% of atomoxetine 0.1% of atomoxetine d N-Desmethylatomoxetine e concentration 5% of atomoxetine 45% of atomoxetine Excretion Urine Greater than 80% of the administered dose excreted as 4-hydroxyatomoxetine-O-glucuronide; Less than 3% as unchanged drug Feces Less than 17% of the administered dose Abbreviations: C max,ss = maximum atomoxetine plasma concentration at steady state; T max = time to peak concentration a In this analysis, other CYP2D6 metabolizer types were defined as individuals who were not CYP2D6 poor metabolizers and included CYP2D6 ultrarapid, normal, and intermediate metabolizers. b CYP2D6 poor metabolizers were defined as individuals with two nonfunctional alleles (e.g., CYP2D6*3/*4, CYP2D6*5/*5), and as a result no CYP2D6 enzyme activity. c Primarily formed by CYP2D6.The major oxidative metabolite formed, regardless of CYP2D6 metabolizer type, and is further glucuronidate… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 42 words ▾

12.1Mechanism of Action The precise mechanism by which atomoxetine produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

📦 How Supplied / Storage and Handling 91 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atomoxetine capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap, imprinted “APO AM10” in black ink. They are supplied as follows: NDC: 70518-4313-00 NDC: 70518-4313-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH 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) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 184 words ▾

11 DESCRIPTION Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride, USP is the R (-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N -Methyl-3-phenyl-3-( o -tolyloxy)- propylamine hydrochloride.

The molecular formula is C 17 H 21 NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride, USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules, USP are for oral administration only.

Each capsule contains atomoxetine hydrochloride, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shells contain gelatin and titanium dioxide.

The capsule shells may also contain one or more of the following: FD&C Blue No. 2 (25 mg, 40 mg, and 60 mg), iron oxide red (80 mg and 100 mg), and iron oxide yellow (18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg). The capsules are imprinted with edible black ink (comprised of ammonia solution, iron oxide black, potassium hydroxide, propylene glycol, and shellac). atomstructure.jpg

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Suicide Risk Patients, their families, and their caregivers should be alerted about the need to monitor patients daily for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during atomoxetine treatment and when the dosage is adjusted.

Such symptoms should be reported to the patient’s health care provider immediately [see Warnings and Precautions ( 5.1 )]. Severe Liver Injury Patients initiating atomoxetine should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions ( 5.2 )].

Serious Cardiovascular Reactions Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine treatment should stop atomoxetine capsules and contact a health care provider [see Warnings and Precautions ( 5.3 )]. Increased Blood Pressure or Heart Rate Atomoxetine can increase blood pressure and heart rate [see Warnings and Precautions ( 5.4 )] . Emergence of New Psychotic or Manic Symptoms and Activation of Mania Instruct patients and their caregivers to look for signs of activation of mania/hypomania and psychosis [see Warnings and Precautions ( 5.5 )].

Aggression or Hostility Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility [see Warnings and Precautions ( 5.7 )]. Priapism The parents or guardians of pediatric patients taking atomoxetine and adult patients taking atomoxetine should be instructed that priapism requires prompt medical attention [see Warnings and Precautions ( 5.10 )]. Ocular Irritant Atomoxetine is an ocular irritant.

Atomoxetine capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Drug-Drug Interactions Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs, dietary supplements, or herbal remedies [see Drug Interactions ( 7 )]. Sexual Dysfunction Advise patients that atomoxetine capsules may impair sexual function. Advise patients if they experience sexual dysfunction, they should contact their health care provider [see Adverse Reactions ( 6.1 )].

Pregnancy Registry Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations ( 8.1 )]. Food Patients may take atomoxetine capsules with or without food. Missed Dose If patients miss a dose, they should be instructed to take it as soon as possible but should not take more than the prescribed total daily amount of atomoxetine in any 24-hour period.

Somnolence The incidence of somnolence was higher in atomoxetine-treated patients than placebo-treated patients [see Adverse Reactions ( 6.1 )] . Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Atomoxetine(a” toe mox’ e teen) Capsules, USP for oral use What is the most important information I should know about atomoxetine capsules? Atomoxetine capsules can cause serious side effects, including: Suicidal thoughts and actions in children 6 years of age and older. Atomoxetine capsules can increase the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.

How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when atomoxetine capsules is started or when the dose is changed.

Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns. Tell your healthcare provider right away if any of the following symptoms develop during treatment, especially if they are new, worse, or worry you: anxiety trouble sleeping acting aggressive extreme increase in activity or talking (mania) unusual decrease in activity (hypomania) feeling agitated or restless irritability impulsivity depression panic attacks restlessness or feeling like you have to move panic attacks hostility or being angry or violent suicide attempts thoughts about suicide or dying other unusual changes in mood or behavior See “What are the possible side effects of atomoxetine capsules?”for more information about side effects.

What are atomoxetine capsules ? Atomoxetine capsules are a prescription medicine used to treat ADHD in adults and children 6 years of age and older. Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. It is not known if atomoxetine capsules are safe and effective in children less than 6 years old. Who should not take atomoxetine capsules?

Do not take atomoxetine capsules if you or your child: are allergic to atomoxetine or any of the ingredients in atomoxetine capsules. See the end of this Medication Guide for a complete list of ingredients in atomoxetine capsules. are taking or have stopped taking within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI). have an eye problem called narrow angle glaucoma. have or had a rare tumor called pheochromocytoma. have severe heart or blood vessel problems that could get worse if your blood pressure or heart rate increases.

Before taking atomoxetine capsules, tell your healthcare provider about all medical conditions, including if you or your child: have, or have a family history of, suicide thoughts or attempts, bipolar disorder, depression, mania, or hypomania. have liver problems. have, or have a family history of, heart problems, heart defects, irregular heartbeat, or sudden death. have high blood pressure or low blood pressure. have problems urinating such as trouble starting urination, weak stream, or not fully emptying the bladder. have glaucoma. are pregnant or plan to become pregnant.

It is not known if atomoxetine will harm the unborn baby. Tell your healthcare provider right away if you or your child become pregnant or plan to become pregnant during treatment with atomoxetine capsules. There is a pregnancy exposure registry for women who are exposed to ADHD medicines, including atomoxetine capsules, during pregnancy.

The purpose of the registry is to collect information about the health of women exposed to atomoxetine and their baby. If you or your child become pregnant during treatment with atomoxetine capsules, talk to your healthcare provider about registering with the National Pr… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetic parameters for atomoxetine and its metabolites in CYP2D6 poor metabolizers and other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) are presented in Table 9. Table 9: Atomoxetine and Metabolite Pharmacokinetics in Adult CYP2D6 Poor Metabolizers and Other CYP2D6 Metabolizer Types Parameter Other CYP2D6 Metabolizer Types a CYP2D6 Poor Metabolizers b Absorption Dose proportionality 10 to 120 mg Accumulation 1.1-fold 3.3-fold Absolute bioavailability 63% 94% T max median 1 hour 2.5 hour Effect of Food AUC: Unchanged; C max : Decreased 37%; T max : Delayed 3 hours Distribution Protein Binding 98% Volume of distribution

0.85L/kg Elimination Atomoxetine half-life 5.2 hours 21.6 hours Atomoxetine apparent oral clearance

0.35 L/hr/kg

0.03L/hr/kg 4-Hydroxyatomoxetine half-life 6 to 8 hours -- N-Desmethylatomoxetine half-life 6 to 8 hours 34 to 40 hours Metabolism Primary metabolic pathways CYP2D6 Other CYP enzymes 4-Hydroxyatomoxetinec concentration 1% of atomoxetine 0.1% of atomoxetine d N-Desmethylatomoxetine e concentration 5% of atomoxetine 45% of atomoxetine Excretion Urine Greater than 80% of the administered dose excreted as 4-hydroxyatomoxetine-O-glucuronide; Less than 3% as unchanged drug Feces Less than 17% of the administered dose Abbreviations: C max,ss = maximum atomoxetine plasma concentration at steady state; T max = time to peak concentration a In this analysis, other CYP2D6 metabolizer types were defined as individuals who were not CYP2D6 poor metabolizers and included CYP2D6 ultrarapid, normal, and intermediate metabolizers. b CYP2D6 poor metabolizers were defined as individuals with two nonfunctional alleles (e.g., CYP2D6*3/*4, CYP2D6*5/*5), and as a result no CYP2D6 enzyme activity. c Primarily formed by CYP2D6.The major oxidative metabolite formed, regardless of CYP2D6 metabolizer type, and is further glucuronidated.

4-Hydroxyatomoxetine is equipotent to atomoxetine as an inhibitor of the norepinephrine transporter. d 4-hydroxyatomoxetine is formed at a slower rate by several other cytochrome P450 enzymes. e Formed by CYP2C19 and other cytochrome P450 enzymes but has substantially (20-fold) less pharmacological activity compared with atomoxetine. Specific Populations Hepatic Impairment: Atomoxetine exposure (AUC) was increased in subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) hepatic impairment compared to subjects with normal hepatic function in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) [see Dosage and Administration ( 2.4 ) and Use in Specific Populations ( 8.6 )].

Renal Impairment: Patients with severe renal impairment (end stage renal disease requiring hemodialysis) had higher systemic atomoxetine exposure (about a 65% increase) than patients with normal renal function (CrCl ≥ 90 ml/minute) in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate), but there was no difference when exposure was corrected for mg/kg dose. Thus, the differences in exposure were not clinically significant. Pediatric Patients: The pharmacokinetics of atomoxetine were evaluated in more than 400 pediatric patients in clinical studies, primarily using population pharmacokinetic modeling.

Single-dose and steady-state individual pharmacokinetic data were also obtained in pediatric patients and adults. When atomoxetine doses were normalized to a mg/kg basis, similar half- life, C max , and AUC values were observed in pediatric patients and adults. Clearance and volume of distribution after adjustment for body weight were also similar.

Sex: Sex did not influence atomoxetine disposition. Ethnic Origin: Ethnic origin did not influence atomoxetine disposition. Drug Interaction Studies Clinical Studies: Strong CYP2D6 Inhibitors: Concomitant use of atomoxetine (20 mg BID for 5 days) with paroxetine (20 mg QD for 17 days), a known inhibitor of CYP2D6, in subjects who were not CYP2D6 po… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics An exposure-response analysis of atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure correlates with efficacy as measured by the ADHD Rating Scale-IV-Parent Version: Investigator administered and scored. The exposure-efficacy relationship was similar to that observed between atomoxetine dosage and efficacy with median atomoxetine exposures at the two highest doses resulting in near maximal changes from baseline [see Clinical Studies ( 14.2 )]. Cardiac Electrophysiology The effect of atomoxetine on QTc interval prolongation was evaluated in a randomized, double-blinded, positive-(moxifloxacin 400 mg) and placebo-controlled, cross-over study in healthy male CYP2D6 poor metabolizers.

A total of 120 healthy subjects were administered atomoxetine (20 mg and 60 mg) twice daily for 7 days. No large changes in QTc interval (i.e., increases >60 msec from baseline, absolute QTc >480 msec) were observed in the study. However, small changes in QTc interval cannot be excluded from this study, because the study failed to demonstrate assay sensitivity.

There was a slight increase in QTc interval with increased atomoxetine concentration. Pharmacodynamic Drug Interaction Studies Consumption of ethanol with atomoxetine did not change the intoxicating effects of ethanol. Concomitant use of atomoxetine with methylphenidate did not increase cardiovascular effects beyond those seen with methylphenidate alone.

Albuterol 600 mcg given intravenously over 2 hours (albuterol is not approved for intravenous use) induced heart rate and blood pressure increases; these effects were potentiated when co-administered with atomoxetine (60 mg twice daily for 5 days), particularly initially [see Drug Interactions (7)].

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1ADHD Studies in Pediatric Patients 6 Years of Age and Older Acute Studies in Pediatric Patients 6 Years of Age and Older with ADHD: The effectiveness of atomoxetine in the treatment of ADHD was established in four randomized, double-blind, placebo-controlled studies of pediatric patients 6 to 18 years of age (Studies 1, 2, 3, and 4). In these studies, approximately one-third of the patients met DSM-IV criteria for inattentive subtype and two-thirds met criteria for both inattentive and hyperactive/impulsive subtypes.

In these studies, signs and symptoms of ADHD were evaluated with the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS) total score including hyperactive/impulsive and inattentive subscales by comparing the mean change from baseline to endpoint in the atomoxetine and placebo groups using an intent-to-treat (ITT) analysis (the primary endpoint). Each item on the ADHDRS maps directly to one symptom criterion for ADHD in the DSM-IV. In Study 1, an 8-week randomized, double-blind, placebo-controlled, dose-response, acute treatment study, pediatric patients 8 to 18 years of age (N=297) received either a fixed dosage of atomoxetine (0.25, 0.6, or 0.9 mg/kg twice daily (in the early morning and late afternoon/early evening) or placebo.

Improvements in ADHD symptoms were statistically significantly superior in patients treated with either of the two higher atomoxetine dosages compared with patients treated with placebo as measured on the ADHDRS scale. The 0.9 mg/kg twice daily atomoxetine dosage did not provide any additional benefit over that observed with the 0.6 mg/kg twice daily atomoxetine dosage. The 0.25 mg/kg twice daily atomoxetine dosage group was not superior to the placebo group.

In Study 2, a 6-week randomized, double-blind, placebo-controlled, acute treatment study, pediatric patients 6 to 16 years of age (N=171) received either atomoxetine or placebo. Atomoxetine was administered as a once daily dose in the early morning and titrated on a weight-adjusted basis according to clinical response, up to a maximum dosage of 1.5 mg/kg once daily. The mean final dosage of atomoxetine was approximately 1.3 mg/kg once daily.

ADHD symptoms were statistically significantly improved in the atomoxetine group compared to the placebo group, as measured on the ADHDRS scale. Study 2 showed that atomoxetine was effective when administered once daily in the morning. In two identically designed, 9-week, acute, double-blind, placebo-controlled studies, pediatric patients 7 to 13 years of age (Study 3, N=147; Study 4, N=144) were randomized to receive atomoxetine, methylphenidate, or placebo.

In Studies 3 and 4, atomoxetine was administered twice daily (in the early morning and late afternoon, after school) and titrated on a weight-adjusted basis according to clinical response up to the maximum recommended atomoxetine dosage of 1 mg/kg twice daily. The mean final dosage of atomoxetine in Studies 3 and 4 was approximately 0.8 mg/kg twice daily. In Studies 3 and 4, ADHD symptoms statistically significantly improved more in the atomoxetine group than the placebo group, as measured on the ADHDRS scale.

Examination of population subsets based on sex and age (<12 and 12 to 17 years of age) in these studies did not reveal any differences in response. There were not sufficient numbers of patients in racial or ethnic groups to determine if there were differences in responses in these subgroups. Maintenance Study in Pediatric Patients 6 Years of Age and Older with ADHD The effectiveness of atomoxetine in the maintenance treatment of ADHD in pediatric patients 6 years of age and older was established in an outpatient randomized withdrawal study of pediatric patients 6 to 15 years of age (Study 5).

In this study, patients who met DSM-IV criteria for ADHD, and showed continuous response for about 4 weeks during an initial 10-week open-label treatment phase with atomoxetine (1.2 to 1.8 mg/… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 120 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Atomoxetine capsules contains atomoxetine which is not a controlled substance.

9.2Abuse In a randomized, double-blind, placebo-controlled, abuse-potential study in adults that compared effects of atomoxetine capsules and placebo, atomoxetine was not associated with stimulant or euphoriant properties. Clinical study data in over 2,000 adults and pediatric patients with ADHD and over 1,200 adults with depression (atomoxetine capsules is not indicated for the treatment of depression) showed only isolated incidents of inappropriate atomoxetine self-administration. Drug discrimination studies in rats and monkeys showed inconsistent stimulus generalization between atomoxetine and cocaine.

9.3Dependence After atomoxetine capsules discontinuation, there was no evidence of symptom rebound or adverse reactions suggesting an atomoxetine capsules-discontinuation or withdrawal syndrome.

🔒 Controlled Substance 13 words ▾

9.1Controlled Substance Atomoxetine capsules contains atomoxetine which is not a controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis — Atomoxetine HCl was not carcinogenic in rats and mice when given in the diet for 2 years at time-weighted average doses up to 47 and 458 mg/kg/day, respectively. The highest dose used in rats is approximately 8 and 5 times the maximum recommended human dose (MRHD) in children and adults, respectively, on a mg/m 2 basis. Plasma levels (AUC) of atomoxetine at this dose in rats are estimated to be 1.8 times (other CYP2D6 metabolizer types) or 0.2 times (CYP2D6 poor metabolizers) those in humans receiving the maximum human dose.

The highest dose used in mice is approximately 39 and 26 times the MRHD in children and adults, respectively, on a mg/m 2 basis. Mutagenesis — Atomoxetine HCl was negative in a battery of genotoxicity studies that included a reverse point mutation assay (Ames Test), an in vitro mouse lymphoma assay, a chromosomal aberration test in Chinese hamster ovary cells, an unscheduled DNA synthesis test in rat hepatocytes, and an in vivo micronucleus test in mice. However, there was a slight increase in the percentage of Chinese hamster ovary cells with diplochromosomes, suggesting endoreduplication (numerical aberration).

The metabolite N-desmethylatomoxetine HCl was negative in the Ames Test, mouse lymphoma assay, and unscheduled DNA synthesis test. Impairment of Fertility — Atomoxetine HCl did not impair fertility in rats when given in the diet at doses of up to 57 mg/kg/day, which is approximately 6 times the MRHD on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis — Atomoxetine HCl was not carcinogenic in rats and mice when given in the diet for 2 years at time-weighted average doses up to 47 and 458 mg/kg/day, respectively. The highest dose used in rats is approximately 8 and 5 times the maximum recommended human dose (MRHD) in children and adults, respectively, on a mg/m 2 basis. Plasma levels (AUC) of atomoxetine at this dose in rats are estimated to be 1.8 times (other CYP2D6 metabolizer types) or 0.2 times (CYP2D6 poor metabolizers) those in humans receiving the maximum human dose.

The highest dose used in mice is approximately 39 and 26 times the MRHD in children and adults, respectively, on a mg/m 2 basis. Mutagenesis — Atomoxetine HCl was negative in a battery of genotoxicity studies that included a reverse point mutation assay (Ames Test), an in vitro mouse lymphoma assay, a chromosomal aberration test in Chinese hamster ovary cells, an unscheduled DNA synthesis test in rat hepatocytes, and an in vivo micronucleus test in mice. However, there was a slight increase in the percentage of Chinese hamster ovary cells with diplochromosomes, suggesting endoreduplication (numerical aberration).

The metabolite N-desmethylatomoxetine HCl was negative in the Ames Test, mouse lymphoma assay, and unscheduled DNA synthesis test. Impairment of Fertility — Atomoxetine HCl did not impair fertility in rats when given in the diet at doses of up to 57 mg/kg/day, which is approximately 6 times the MRHD on a mg/m 2 basis.

📄 Package Label / Principal Display Panel 54 words ▾

DRUG: Atomoxetine Hydrochloride GENERIC: atomoxetine hydrochloride DOSAGE: CAPSULE ADMINSTRATION: ORAL NDC: 70518-4313-0 NDC: 70518-4313-1 COLOR: white SHAPE: CAPSULE SCORE: No score SIZE: 14 mm IMPRINT: APO;AM10 PACKAGING: 1 in 1 POUCH OUTER PACKAGING: 30 in 1 BOX ACTIVE INGREDIENT(S): ATOMOXETINE HYDROCHLORIDE 10mg in 1 INACTIVE INGREDIENT(S): TITANIUM DIOXIDE STARCH, CORN GELATIN, UNSPECIFIED MM1 Remedy_Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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Orange Book / therapeutic-equivalence data ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70518-4312-00 · REMEDYREPACK 70518-4314-00 · REMEDYREPACK →
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