NDC Code(s) : 72789-286-60
Packager : PD-Rx Pharmaceuticals, Inc.

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:72789-286(NDC:68180-260)
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 ACID250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
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 white Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code L088
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72789-286-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/11/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209286 09/18/2020

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(72789-286)

PRINCIPAL DISPLAY PANEL

Divalproex Sodium Extended-release Tablets, USP

250 mg Valproic Acid Activity

Rx only

Dispense with Medication Guide provided separately to each patient.

72789286 Label