382 Pill — WHITE CAPSULE, 17mm — Quetiapine

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Imprint382
ColourWHITE
ShapeCAPSULE
Size17
StrengthQUETIAPINE FUMARATE 200 mg
Dosage formTablet, Film Coated, Extended Release
ManufacturerAkron Pharma Inc
NDC71399-2000
Schedule—
Availability—
IngredientsQUETIAPINE FUMARATE[QUETIAPINE]

What does this imprint mean?

The imprint "382" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Quetiapine

Uses and warnings

BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA: "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death." Quetiapine is not approved for this population. SUICIDAL THOUGHTS AND BEHAVIORS: Increased risk documented in children, adolescents, and young adults; close monitoring required. | - Cerebrovascular accidents and stroke risk in elderly dementia patients - Neuroleptic Malignant Syndrome (NMS) - potentially fatal - Metabolic changes: hyperglycemia, dyslipidemia, weight gain - Tardive dyskinesia (involuntary movements) - Orthostatic hypotension and syncope - Seizures in susceptible patients - QT prolongation in overdose scenarios

Quetiapine is "indicated for the treatment of: Schizophrenia... Bipolar I disorder manic episodes... Bipolar disorder, depressive episodes." Used for acute and maintenance treatment across these psychiatric conditions in adults and pediatric patients (ages 10+).

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 160c21c2-63f7-49a9-aa10-9767a153cf18.xml