NDC Code(s) : 63739-553-10, 63739-554-10
Packager : McKesson Packaging Services a business unit of McKesson Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex SodiumDivalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-553(NDC:16714-512)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Divalproex sodium(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI) 		VALPROIC ACID250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN (Pale Brown) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code 512
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-553-1010 in 1 BOX, UNIT-DOSE
110 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078853 01/23/2012
Divalproex SodiumDivalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-554(NDC:16714-513)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Divalproex sodium(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI) 		VALPROIC ACID500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 513
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-554-1010 in 1 BOX, UNIT-DOSE
110 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078853 01/23/2012

PRINCIPAL DISPLAY PANEL

Divalproex Sodium 250mg Label

PRINCIPAL DISPLAY PANEL

Divalproex Sodium 500mg Label