NDC Code(s) : 66689-401-01, 66689-401-50, 66689-403-16
Packager : VistaPharm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycodone HydrochlorideOxycodone Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-401
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLOXAMER 188(UNII: LQA7B6G8JG)
SORBITOL(UNII: 506T60A25R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color red Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66689-401-505 in 1 CASE 15/03/2012
110 in 1 TRAY
1NDC:66689-401-015 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201194 03/15/2012
Oxycodone HydrochlorideOxycodone Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-403
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLOXAMER 188(UNII: LQA7B6G8JG)
SORBITOL(UNII: 506T60A25R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color red Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66689-403-16500 mL in 1 BOTTLE Type 0: Not a Combination Product15/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201194 03/15/2012

LABELER - VistaPharm, Inc.(116743084)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Oxycodone

Hydrochloride Oral Solution, USP CII

5 mg per 5 mL
(1 mg/mL)

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Delivers 5 mL

Store at  20°-25°C (68°-77°F); see USP CRT conditions.

XACTDOSE

Manufactured by:

VistaPharm®

Largo, FL 33771, USA

Rx Only

 VP2012R3

06/18

NDC 66689-401-01

lidding-label

PRINCIPAL DISPLAY PANEL

NDC 66689-403-16

Oxycodone Hydrochloride Oral Solution, USP CII

5 mg per 5 mL

(1 mg/mL)

PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.

Each 5 mL Contains:

Oxycodone Hydrochloride, USP ........................................... 5 mg

DO NOT USE IF SEAL UNDER CAP IS MISSING OR BROKEN.

USUAL DOSAGE: See package insert for complete prescribing information.

STORAGE: Store at controlled room temperature 20°- 25°C (68° - 77°F); excursions are permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]

FOR ORAL USE ONLY

500 mL

Dispense solution in original container (bottle) with the provided calibrated measuring cup.

Keep in secured area and protect from diversion.

Manufactured by: VistaPharm, Inc., Largo, FL 33771, USA

Rx Only

VistaPharm

VP2011R3

08/18

container-label

PRINCIPAL DISPLAY PANEL

NDC 66689-403-16

Oxycodone Hydrochloride Oral Solution, USP CII

5 mg per 5 mL

 (1 mg/mL)

PHARMACIST: DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT. 

Each 5 mL Contains:

Oxycodone Hydrochloride, USP..............5 mg

500 mL

Rx Only

VistaPharm

carton-label