Divalproex Sodium (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Divalproex Sodium Extended-Release Tablets USP, 250 mg -- 100T
(click image for full-size original)
Divalproex Sodium Extended-Release Tablets USP, 500 mg -- 100T
(click image for full-size original)
DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-380
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
ETHYLCELLULOSE (10 MPA.S)
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
HYPROMELLOSE 2208 (15000 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
PROPYL GALLATE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score no score
Shape OVAL Size 16mm
Flavor Imprint Code U;380
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-380-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:29300-380-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214643 02/25/2022
DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-381
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM (VALPROIC ACID) VALPROIC ACID 500 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2208 (15000 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
PROPYL GALLATE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 19mm
Flavor Imprint Code U;381
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-381-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:29300-381-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214643 02/25/2022
Labeler — Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 07/2023 Unichem Pharmaceuticals (USA), Inc.

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