NDC Code(s) : 52125-048-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-048(NDC:10370-511)
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
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POVIDONE K12(UNII: 333AG72FWJ)
POLYETHYLENE GLYCOL 1000000(UNII: HZ58M6D839)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color white Score no score
Shape OVAL (TABLET, FILM COATED, EXTENDED RELEASE) Size 19 mm
Flavor Imprint Code A511
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-048-0230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078445 02/28/2013

PRINCIPAL DISPLAY PANEL

DRUG: Divalproex Sodium
GENERIC: Divalproex Sodium
DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 52125-048-02
STRENGTH:500 mg
COLOR: white
SHAPE: OVAL
SCORE: No score
SIZE: 19 mm
IMPRINT: 30
QTY: 30

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