NDC Code(s) : 70954-600-10
Packager : ANI Pharmaceuticals, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluoxetine Hydrochloride Fluoxetine Hydrochloride SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE(UNII: I9W7N6B1KJ)
(FLUOXETINE - UNII:01K63SUP8D) 		FLUOXETINE20 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCROSE(UNII: C151H8M554)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Product Characteristics
Color YELLOW (Clear to pale yellow) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-600-10120 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216448 11/09/2022

LABELER - ANI Pharmaceuticals, Inc.(145588013)

Establishment
Name Address ID/FEI Business Operations
Novitium Pharma LLC 080301870 ANALYSIS(70954-600), LABEL(70954-600), MANUFACTURE(70954-600), PACK(70954-600)

PRINCIPAL DISPLAY PANEL

Fluoxetine Oral Solution, USP 20 mg/5 mL - NDC 70954-600-10: 4 fl. oz (120 mL) bottle

label