Atomoxetine 40 mg/1
Atomoxetine · CAPSULE · Bryant Ranch Prepack
Atomoxetine is a capsule containing atomoxetine at 40 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Atomoxetine
- Generic Name
- Atomoxetine
- NDC Code (Product)
72162-2544- Manufacturer
- Bryant Ranch Prepack
- Strength
- 40 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079021
- Marketing Start
- 07/01/2025
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Aidapak Services, LLC
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Aidapak Services, LLC
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies ( 14 )]. 1.2 Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. Th…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial, Target and Maximum Daily Dose ( 2.1 ) (Acute and Maintenance/Extended Treatment) Body Weight Initial Daily Dose Target Total Daily Dose Maximum Total Daily Dose Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( 2.4 , 12.3 ) 2.1 Acute Treatment Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see Clinical Studies ( 14 )]. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less. Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiate…
Contraindications
4 CONTRAINDICATIONS • Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) • Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. ( 4.2 , 7.1 ) • Narrow Angle Glaucoma. ( 4.3 ) • Pheochromocytoma or history of pheochromocytoma.( 4.4 ) • Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP. ( 4.5 ) 4.1 Hypersensitivity Atomoxetine capsules are contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions ( 5.8 )]. 4.2 Monoamine Oxidase Inhibitors (MAOI) Atomoxetine capsules should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing atomoxetine capsules. 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 deliriu…
Drug Interactions
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 exposure…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) • Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months. 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. Child and Adolescent Clinical Trials Reasons for discontinuation of trea…
Frequently Asked Questions
What is Atomoxetine used for?
Atomoxetine contains Atomoxetine. It is a capsule taken oral. Consult your doctor for specific uses.
Is Atomoxetine a controlled substance?
Atomoxetine is not classified as a controlled substance by the DEA.
What is the generic name for Atomoxetine?
The generic name for Atomoxetine is Atomoxetine. There are 5 other brand versions of Atomoxetine.
What is the NDC code for Atomoxetine 40 mg/1?
The NDC (National Drug Code) for Atomoxetine 40 mg/1 is 72162-2544, listed by Bryant Ranch Prepack.