OXYCODONE HYDROCHLORIDE

Basic Information

Product Name

FDA Product Code

67296-1376

Regulatory Information

NDC Product Code

67296-1376

Application Number

NDA022272

Marketing Category

C73605

Effective Date

January 21, 2022

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

OXYCODONE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: C1ENJ2TE6C

Class Code: ACTIB

Inactive Ingredients

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

OXYCODONE

Code: CD35PMG570

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

BUTYLATED HYDROXYTOLUENE

POLYETHYLENE GLYCOL, UNSPECIFIED

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 400

HYPROMELLOSES

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

MAGNESIUM STEARATE

Active Moieties

OXYCODONE