OxyContin

Basic Information

Product Name

OxyContin

FDA Product Code

59011-440

Regulatory Information

NDC Product Code

59011-440

Application Number

NDA022272

Marketing Category

C73594

Effective Date

March 28, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use OXYCONTIN safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN (oxycodone hydrochloride) extended-release tablets, for oral use, CIIInitial U.S. Approval: 1950

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

OXYCODONE HYDROCHLORIDE

Quantity: 40 mg in 1 1

Code: C1ENJ2TE6C

Class Code: ACTIB

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties

OXYCODONE

Code: CD35PMG570

Basic Information

Regulatory Information

Company Information

Active Ingredients

BUTYLATED HYDROXYTOLUENE

HYPROMELLOSES

POLYETHYLENE GLYCOL 400

MAGNESIUM STEARATE

TITANIUM DIOXIDE

FERRIC OXIDE YELLOW

POLYSORBATE 80

Active Moieties

OXYCODONE