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FDA Drug information

Divalproex Sodium

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221013

Version

6

Spl Product Data Elements

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

Application Number

ANDA078239

Brand Name

Divalproex Sodium

Generic Name

Divalproex Sodium

Product Ndc

65841-637

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

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

SPL MEDGUIDE Manufactured by: Cadila Healthcare Ltd. India.

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