NDC Code(s) : 81033-066-20
Packager : Kesin Pharma Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LIKMEZMetronidazole Oral SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81033-066
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metronidazole(UNII: 140QMO216E)
(METRONIDAZOLE - UNII:140QMO216E) 		metronidazole100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
PEPPERMINT(UNII: V95R5KMY2B)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM PHOSPHATE DIBASIC DIHYDRATE(UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT, STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:81033-066-20200 mL in 1 BOTTLE Type 0: Not a Combination Product13/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216755 10/13/2023

LABELER - Kesin Pharma Corporation(117447816)

REGISTRANT - Saptalis Pharmaceuticals, LLC(081154447)

Establishment
Name Address ID/FEI Business Operations
Saptalis Pharmaceuticals, LLC 081154447 manufacture(81033-066)

PRINCIPAL DISPLAY PANEL

NDC 81033-066-20

LIKMEZTM

(metronidazole) Oral Supension

500 mg/mL

(100 mg/mL)

Strawberry Peppermint Flavor

For Oral Use Only

Rx only

200 mL

Label