Oxycodone Hydrochloride (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

carton -- 30 mL
(click image for full-size original)

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

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