NDC Code(s) : 71335-1883-1, 71335-1883-2, 71335-1883-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex sodiumDivalproex sodium TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1883(NDC:68180-261)
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code L089
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1883-160 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
2NDC:71335-1883-230 in 1 BOTTLE Type 0: Not a Combination Product21/06/2021
3NDC:71335-1883-390 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209286 09/18/2020

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-1883), RELABEL(71335-1883)

PRINCIPAL DISPLAY PANEL

Divalproex Sod. 500mg ER Tablet

Label