Divalproex Sodium (Page 14 of 14)

Package/Label Display Panel

Divalproex Sodium Extended-release Tablets, USP, 250 mg

NDC 68001-105-00, 100 Tablets

Divalproex Sodium ER Tablets 250mg 100Tablets Rev 04-17
(click image for full-size original)

Package/Label Display Panel

Divalproex Sodium Extended-release Tablets, USP, 500 mg

NDC 68001-106-00, 100 Tablets

Divalproex Sodium ER Tablets 500mg 100Tablets Rev 04-17
(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:68001-105
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
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:68001-105-00 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-105-03 500 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 10/08/2013
DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-106
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
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:68001-106-00 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-106-03 500 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 10/08/2013
Labeler — BluePoint Laboratories (985523874)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (68001-105), ANALYSIS (68001-106), MANUFACTURE (68001-105), MANUFACTURE (68001-106)

Revised: 07/2020 BluePoint Laboratories

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