NDC 71335-1883-3
API & Excipient Details

Divalproex Sodium marketed by Bryant Ranch Prepack under NDC Code 71335-1883-3

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIVALPROEX SODIUM(UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)	VALPROIC ACID	500 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71335-1883-1	60 in 1 BOTTLE Type 0: Not a Combination Product	07/06/2022
2	NDC:71335-1883-2	30 in 1 BOTTLE Type 0: Not a Combination Product	21/06/2021
3	NDC:71335-1883-3	90 in 1 BOTTLE Type 0: Not a Combination Product	07/06/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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