Divalproex Sodium: Package Insert and Label Information (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50
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30
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DIVALPROEX SODIUM divalproex sodium tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-259(NDC:65162-755)
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
ETHYL ACRYLATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
HYPROMELLOSES
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
BUTYL ALCOHOL
POLYVINYL ALCOHOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;755
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-259-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-259-11)
1 NDC:50268-259-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50268-259-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203730 09/16/2022
DIVALPROEX SODIUM divalproex sodium tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-260(NDC:65162-757)
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
ETHYL ACRYLATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
HYPROMELLOSES
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
BUTYL ALCOHOL
POLYVINYL ALCOHOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code AN;757
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-260-13 30 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-260-11)
1 NDC:50268-260-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50268-260-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203730 09/16/2022
Labeler — AvPAK (832926666)

Revised: 09/2022 AvPAK

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