NDC Code(s) : 61786-079-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex SodiumDivalproex Sodium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-079(NDC:29300-140)
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
ALCOHOL(UNII: 3K9958V90M)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
VANILLIN(UNII: CHI530446X)
Product Characteristics
Color pink (Reddish Pink) Score no score
Shape OVAL (capsule-shaped) Size 19 mm
Flavor Imprint Code UL;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-079-0230 in 1 BLISTER PACK Type 0: Not a Combination Product05/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079163 11/05/2014 02/08/2017

PRINCIPAL DISPLAY PANEL

DRUG: Divalproex Sodium

GENERIC: Divalproex Sodium

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-079-02

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: UL;500

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DIVALPROEX SODIUM 500mg in 1

INACTIVE INGREDIENT(S):

  • ALCOHOL
  • SODIUM LAURYL SULFATE
  • SODIUM BICARBONATE
  • SILICON DIOXIDE
  • STARCH, PREGELATINIZED CORN
  • SHELLAC
  • TRIETHYL CITRATE
  • TALC
  • TITANIUM DIOXIDE
  • TRIACETIN
  • PROPYLENE GLYCOL
  • CELLULOSE, MICROCRYSTALLINE
  • FD&C RED NO. 40
  • FERROSOFERRIC OXIDE
  • BUTYL ALCOHOL
  • HYPROMELLOSE 2910 (6 MPA.S)
  • LACTOSE MONOHYDRATE
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
  • POLYETHYLENE GLYCOL 3000
  • ISOPROPYL ALCOHOL
  • VANILLIN

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