Oxcarbazepine (Page 10 of 10)

Package/Label Display Panel

Oxcarbazepine Oral Suspension, USP — Bottle Label

300 mg/5 mL, 250 mL

NDC 0054-0199-59

oxcarb-os-bl-300mg-5ml-c50000668-01-k03
(click image for full-size original)

Package/Label Display Panel

Oxcarbazepine Oral Suspension, USP — Folding Carton

300 mg/5 mL, 250 mL

NDC 0054-0199-59

oxcarb-os-fc-300mg-5ml-c50000669-01-k02
(click image for full-size original)
OXCARBAZEPINE
oxcarbazepine suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0199
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 300 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
METHYLPARABEN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
PROPYLPARABEN
POLYSORBATE 80
WATER
SACCHARIN SODIUM ANHYDROUS
SORBIC ACID
SUCROSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Product Characteristics
Color Score
Shape Size
Flavor LEMON (Lemon-Lime) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0199-59 250 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201193 10/03/2012
Labeler — Hikma Pharmaceuticals USA Inc. (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0199)

Revised: 09/2022 Hikma Pharmaceuticals USA Inc.

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