4365 200 Pill — WHITE ROUND, 10mm — Labetalol

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Imprint4365 / 200
ColourWHITE
ShapeROUND
Size10
StrengthLABETALOL HYDROCHLORIDE 200 mg
Dosage formTablet, Film Coated
ManufacturerPhysicians Total Care, Inc.
NDC54868-4844
Schedule—
Availability—
IngredientsLABETALOL HYDROCHLORIDE[LABETALOL]

What does this imprint mean?

The imprint "4365 200" 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

Labetalol

Uses and warnings

No boxed warning. The label's key cautions include rare "severe hepatocellular injury, confirmed by rechallenge in at least one case," with periodic liver function testing recommended; abrupt-withdrawal risk, so when discontinuing "chronically administered TRANDATE Tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks"; and that "patients with bronchospastic disease should, in general, not receive beta-blockers."

TRANDATE Tablets are indicated in the management of hypertension," used alone or combined with other antihypertensive agents, "especially thiazide and loop diuretics.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 5f16b396-90a5-4159-bd8e-71f7f7128f34.xml