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FDA Drug information

Divalproex Sodium

Read time: 1 mins
Marketing start date: 28 May 2024

Summary of product characteristics


Effective Time

20230921

Version

9

Spl Product Data Elements

Divalproex Sodium Divalproex Sodium DIVALPROEX SODIUM VALPROIC ACID AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE HYPROMELLOSES ISOPROPYL ALCOHOL MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TRIETHYL CITRATE WHITE TO OFF WHITE OVAL ZA08 Divalproex Sodium Divalproex Sodium DIVALPROEX SODIUM VALPROIC ACID AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE HYPROMELLOSES ISOPROPYL ALCOHOL MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TRIETHYL CITRATE WHITE TO OFF-WHITE OVAL ZA07 Divalproex Sodium Divalproex Sodium DIVALPROEX SODIUM VALPROIC ACID AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE HYPROMELLOSES ISOPROPYL ALCOHOL MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TRIETHYL CITRATE WHITE TO OFF WHITE OVAL ZA06

Application Number

ANDA077100

Brand Name

Divalproex Sodium

Generic Name

Divalproex Sodium

Product Ndc

65841-635

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-634-01 in bottle of 100 tablets Divalproex Sodium Delayed-release Tablets USP, 125 mg Rx only 100 tablets NDC 65841-635-01 in bottle of 100 tablets Divalproex Sodium Delayed-release Tablets USP, 250 mg Rx only 100 tablets NDC 65841-636-01 in bottle of 100 tablets Divalproex Sodium Delayed-release Tablets USP, 500 mg Rx only 100 tablets Divlaproex Sodium DR Tablets USP, 125 mg Divlaproex Sodium DR Tablets USP, 250 mg Divlaproex Sodium DR Tablets USP, 500 mg

Spl Medguide

SPL MEDGUIDE

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