Divalproex Sodium

DIVALPROEX SODIUM- divalproex sodium tablet, film coated, extended release
Cadila Healthcare Limited

SPL MEDGUIDE

Manufactured by:

Cadila Healthcare Ltd.

India.

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

DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-637 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 250 mg

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code ZA47 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-637-14 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:65841-637-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:65841-637-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:65841-637-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078239 01/07/2013

DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-638 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 500 mg

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code ZA48 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-638-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:65841-638-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:65841-638-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078239 01/07/2013

Labeler — Cadila Healthcare Limited (918596198)

Registrant — Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		918596198	ANALYSIS (65841-637), ANALYSIS (65841-638), MANUFACTURE (65841-637), MANUFACTURE (65841-638)

Revised: 08/2020 Cadila Healthcare Limited