383 Pill — YELLOW CAPSULE, 19mm — Quetiapine

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Imprint383
ColourYELLOW
ShapeCAPSULE
Size19
StrengthQUETIAPINE FUMARATE 300 mg
Dosage formTablet, Film Coated, Extended Release
ManufacturerScieGen Pharmaceuticals, Inc.
NDC50228-383
Schedule—
AvailabilityPrescription only
IngredientsQUETIAPINE FUMARATE[QUETIAPINE]

What does this imprint mean?

The imprint "383" 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 c42221bd-5cc2-4b6e-a4eb-0d0c2e2c27ab.xml