NDC Code(s) : 49349-072-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-072
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
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ISOBUTYL ALCOHOL(UNII: 56F9Z98TEM)
PEG-12 LAURATE(UNII: SP6SI08H7T)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
PHENOXYISOPROPANOL(UNII: 87CZY0NY1A)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score no score
Shape OVAL (TABLET, DELAYED RELEASE) Size 19 mm
Flavor Imprint Code 93;7441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-072-0230 in 1 BLISTER PACK Type 0: Not a Combination Product16/11/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076941 11/16/2010 11/17/2011

PRINCIPAL DISPLAY PANEL

DRUG: DIVALPROEX SODIUM DELAYED RELEASE

GENERIC: DIVALPROEX SODIUM DELAYED RELEASE

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 49349-072-02

STRENGTH:500 mg

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: 93;7441

QTY: 30

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