797 Pill — ORANGE OVAL, 15mm — Divalproex

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Imprint797
ColourORANGE
ShapeOVAL
Size15
StrengthDIVALPROEX SODIUM 250 mg
Dosage formTablet, Delayed Release
ManufacturerContract Pharmacy Services-PA
NDC67046-145
Schedule—
Availability—
IngredientsDIVALPROEX SODIUM[VALPROIC ACID]

What does this imprint mean?

The imprint "797" 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

Divalproex

Uses and warnings

BOXED WARNING describing three life-threatening risks. Hepatotoxicity: "hepatic failure resulting in fatalities has occurred... usually during the first six months of treatment," with children under two and patients with mitochondrial disorders at greatest risk. Fetal risk: "valproate can cause major congenital malformations, particularly neural tube defects" and "decreased IQ scores and neurodevelopmental disorders following in utero exposure," so it should not be used for migraine prophylaxis in pregnant women or those of childbearing potential unless no alternative is acceptable. Pancreatitis: "life-threatening pancreatitis... some described as hemorrhagic with rapid progression from initial symptoms to death." Contraindicated in hepatic disease, known urea cycle disorders, known POLG-related mitochondrial disorders, and in pregnancy for migraine prevention.

Divalproex sodium is indicated for: "treatment of the manic episodes associated with bipolar disorder," "monotherapy and adjunctive therapy of complex partial seizures" and simple and complex absence seizures, and "prophylaxis of migraine headaches."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 59b94f04-42a1-2100-e053-2991aa0ab8f1.xml