Divalproex Sodium (Page 12 of 12)

Package Label. Principal Display Panel

Divalproex Sodium Delayed-release Capsules USP, 125 mg -100’s Container

Unvarinished Area consists of: 2D Barcode, LOT number, Expiry Date and Serial Number.

Container
(click image for full-size original)
DIVALPROEX SODIUM divalproex sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-532
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
divalproex sodium (valproic acid) valproic acid 125 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide
D&C Red No. 28
FD&C Blue No. 1
ethylcelluloses
gelatin
hypromelloses
magnesium stearate
raw sugar
titanium dioxide
triethyl citrate
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code THIS;END;UP;RDY;532
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-532-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-532-01 100 CAPSULE in 1 BOTTLE None
3 NDC:55111-532-05 500 CAPSULE in 1 BOTTLE None
4 NDC:55111-532-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-532-79)
4 NDC:55111-532-79 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (55111-532-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078979 01/23/2009
Labeler — Dr. Reddy’s Laboratories Ltd (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO III 918608162 manufacture (55111-532), analysis (55111-532)

Revised: 03/2023 Dr. Reddy’s Laboratories Ltd

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