54 531 Pill — WHITE OVAL, 7mm — Quetiapine
| Imprint | 54 / 531 |
|---|---|
| Colour | WHITE |
| Shape | OVAL |
| Size | 7 |
| Strength | QUETIAPINE FUMARATE 300 mg |
| Dosage form | Tablet |
| Manufacturer | Aphena Pharma Solutions - Tennessee, LLC |
| NDC | 43353-004 |
| Schedule | — |
| Availability | — |
| Ingredients | QUETIAPINE FUMARATE[QUETIAPINE] |
What does this imprint mean?
The imprint "54 531" 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+).
How to identify this pill
- • Check the imprint matches exactly: "54 531".
- • Confirm the colour (WHITE) and shape (OVAL).
- • Compare the size (7) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 02d04e01-a007-457d-9200-990cd737611e.xml