NDC Code(s) : 69189-0610-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0610(NDC:10370-510)
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
HYPROMELLOSES(UNII: 3NXW29V3WO)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POVIDONES(UNII: FZ989GH94E)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code A510
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0610-11 in 1 DOSE PACK Type 0: Not a Combination Product13/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078445 04/13/2016

PRINCIPAL DISPLAY PANEL

Divalproex CR 250 mg tablet