NDC Code(s) : 31722-687-25
Packager : Camber Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OXCARBAZEPINE OXCARBAZEPINE SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-687
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE(UNII: VZI5B1W380)
(OXCARBAZEPINE - UNII:VZI5B1W380) 		OXCARBAZEPINE60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
METHYLPARABEN(UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
NONCRYSTALLIZING SORBITOL SOLUTION(UNII: 9E0S3UM200)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SORBIC ACID(UNII: X045WJ989B)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
WATER(UNII: 059QF0KO0R)
LEMON(UNII: 24RS0A988O)
Product Characteristics
Color white (off-white to slightly brown or slightly red) Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31722-687-251 in 1 CARTON 20/10/2023
1250 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216749 10/20/2023

LABELER - Camber Pharmaceuticals, Inc.(826774775)

Establishment
Name Address ID/FEI Business Operations
Hetero Labs Limited Unit III 676162024 manufacture(31722-687)

PRINCIPAL DISPLAY PANEL


Oxcarbazepine Oral Suspension, 300 mg/5 mL Carton Label


oxcarbazepine-fgure17

Oxcarbazepine Oral Suspension, 300 mg/5 mL Container Label


oxcarbazepine-fgure17