Divalproex Sodium (Page 15 of 15)

PRINCIPAL DISPLAY PANEL

DRUG: Divalproex Sodium

GENERIC: Divalproex Sodium

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0463-0

NDC: 70518-0463-1

NDC: 70518-0463-2

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 15 mm

IMPRINT: 797

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • DIVALPROEX SODIUM 250mg in 1

INACTIVE INGREDIENT(S):

  • TALC
  • PROPYLENE GLYCOL
  • BUTYL ALCOHOL
  • FERROSOFERRIC OXIDE
  • SHELLAC
  • FERRIC OXIDE YELLOW
  • FD&C YELLOW NO. 6
  • SODIUM LAURYL SULFATE
  • SODIUM BICARBONATE
  • TRIETHYL CITRATE
  • METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
  • TRIACETIN
  • TITANIUM DIOXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • POVIDONE, UNSPECIFIED
  • STARCH, CORN
  • AMMONIA
  • SILICON DIOXIDE
Remedy_Label
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MM2
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MM3
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DIVALPROEX SODIUM divalproex sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0463(NDC:62756-797)
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
SILICON DIOXIDE
STARCH, CORN
POVIDONE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIETHYL CITRATE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
TALC
Product Characteristics
Color orange Score no score
Shape OVAL Size 15mm
Flavor Imprint Code 797
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0463-0 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK None
2 NDC:70518-0463-1 100 POUCH in 1 BOTTLE, UNIT-DOSE contains a POUCH (70518-0463-2)
2 NDC:70518-0463-2 1 TABLET, DELAYED RELEASE in 1 POUCH This package is contained within the BOTTLE, UNIT-DOSE (70518-0463-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078597 04/25/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2021 REMEDYREPACK INC.

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