Oxycodone Hydrochloride (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

AKORN

NDC 50383-964-30

Oxycodone Hydrochloride Oral Solution, USP

100 mg/5 mL

(20 mg/mL)

CAUTION! HIGHLY CONCENTRATED SOLUTION! VERIFY DOSAGE AND MEASURE CAREFULLY.

ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT

Each 1 mL of Oxycodone Hydrochloride Oral Solution Contains:

Oxycodone Hydrochloride, USP ……… 20 mg

Dispense the enclosed Medication Guide to each patient.

Rx only

30 mL

OXYCODONE HYDROCHLORIDE oxycodone hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-964 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 POLOXAMER 188 WATER TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE SACCHARIN SODIUM SORBITOL

Product Characteristics Color YELLOW (A clear, yellow solution) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-964-30 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 mL in 1 BOTTLE This package is contained within the CARTON (50383-964-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208795 08/07/2017

Labeler — Akorn (117696873)

Registrant — Akorn Operating Company LLC (117693100)

Establishment
Name	Address	ID/FEI	Operations
Akorn		117696873	MANUFACTURE (50383-964)

Revised: 11/2022 Akorn