Divalproex Sodium (Page 12 of 12)

PACKAGE LABEL

Label Image for 53808-1065 250mg

Label Image for 250mgLabel Image for 250mg
DIVALPROEX SODIUM divalproex sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1065(NDC:57237-047)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 250 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONE K30
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
TALC
METHYLENE CHLORIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
DIETHYL PHTHALATE
HYPROMELLOSE 2910 (15 MPA.S)
TRIACETIN
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
LECITHIN, SOYBEAN
VANILLIN
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
SHELLAC
ISOPROPYL ALCOHOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color ORANGE (Peach) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code D;85
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1065-1 30 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090554 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1065)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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