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Divalproex sodium - Medication Information

Product NDC Code 65841-638
Drug Name

Divalproex sodium

Type Generic
Pharm Class Anti-epileptic Agent [EPC],
Decreased Central Nervous System Disorganized Electrical Activity [PE],
Mood Stabilizer [EPC]
Active Ingredients
Divalproex sodium 500 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
RxCUI drug identifier 1099563,
1099569
Application Number ANDA078239
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-638-01 100 tablet, film coated, extended release in 1 bottle (65841-638-01)
65841-638-05 500 tablet, film coated, extended release in 1 bottle (65841-638-05)
65841-638-16 90 tablet, film coated, extended release in 1 bottle (65841-638-16)
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Spl product data elements

Usually a list of ingredients in a drug product.
Divalproex Sodium Divalproex Sodium DIVALPROEX SODIUM VALPROIC ACID AMMONIA BUTYL ALCOHOL FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE CAPSULE ZA47 Divalproex Sodium Divalproex Sodium DIVALPROEX SODIUM VALPROIC ACID AMMONIA BUTYL ALCOHOL FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE CAPSULE ZA48

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-637-01 in bottle of 100 tablets Divalproex Sodium ER Tablets, 250 mg Rx only 100 tablets NDC 65841-638-01 in bottle of 100 tablets Divalproex Sodium ER Tablets, 500 mg Rx only 100 tablets Structured product formula for Divalproex Structured product formula for Divalproex

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE Manufactured by: Cadila Healthcare Ltd. India.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API