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

Structured product formula for Divalproex
(click image for full-size original)

NDC 65841-638-01 in bottle of 100 tablets

Divalproex Sodium ER Tablets, 500 mg

Rx only

100 tablets

Structured product formula for Divalproex
(click image for full-size original)
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

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