Product Details

Divalproex Sodium DR Tablets, USP

Pronunciation: die-VAL-pro-ex soh-dee-um

Strength:
500mg
NDC-9:
68382-0033
Dosage Form:
DR Tablet
TE Code:
AB
Reference Listed Drug:
Depakote®
Shape:
Oval
Color:
White to Off-White
Imprint Code:
ZA06
Therapeutic Category:
Anticonvulsant
Product Status:
Discontinued
Divalproex Sodium DR Tablets, USP

* NOT TO SCALE

Indications

Mania Divalproex sodium delayed-release tablets, USP are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed-release tablets, USP was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania. The safety and effectiveness of divalproex sodium delayed-release tablets, USP for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets, USP for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Epilepsy Divalproex sodium delayed-release tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets, USP are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Migraine Divalproex sodium delayed-release tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets, USP are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets, USP should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment.

Special Instructions

Keep this product, and all medications, out of the reach of children. Store at 20° - 25°C (68° - 77°F). Dispense in light-resistant container.

Allergen Information

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Case Information

Bottle of 100Bottle of 500 
NDC:68382-0033-0168382-0033-05 
UPC:368382033017368382033055 
Case Qty:2412 
Case Dimensions (LxWxH - inches):16.02 x 10.75 x 5.3516.65 x 12.52 x 8.31 
Case Weight:9.15lbs18.20lbs 
Bottle Dimensions (WxH - inches):2.400 x 4.2503.770 x 7.250 
Bottle Size:225cc950cc 
Product Shelf Life (months):2424