501 Pill — WHITE OVAL, 16mm — Mirtazapine
| Imprint | 501 |
|---|---|
| Colour | WHITE |
| Shape | OVAL |
| Size | 16 |
| Strength | MIRTAZAPINE 45 mg |
| Dosage form | Tablet |
| Manufacturer | NorthStar Rx LLC |
| NDC | 16714-709 |
| Schedule | — |
| Availability | — |
| Ingredients | MIRTAZAPINE[MIRTAZAPINE] |
What does this imprint mean?
The imprint "501" 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
Mirtazapine
Uses and warnings
BOXED WARNING: "Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults," and prescribers are instructed to "balance this risk with the clinical need," with close monitoring advised, especially early in treatment and after dose changes. Concomitant use with a monoamine oxidase inhibitor "is contraindicated," as is starting mirtazapine within 14 days of stopping an MAOI. Other major warnings include agranulocytosis/severe neutropenia, serotonin syndrome risk with other serotonergic or dopaminergic drugs, activation of mania/hypomania, seizures, and hyponatremia.
"REMERON (mirtazapine) Tablets are indicated for the treatment of major depressive disorder," with efficacy established in placebo-controlled trials of outpatients meeting DSM criteria for a major depressive episode.
How to identify this pill
- • Check the imprint matches exactly: "501".
- • Confirm the colour (WHITE) and shape (OVAL).
- • Compare the size (16) 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 67e43ea4-a86e-4493-8835-1da78777976a.xml