Prescription Drug Information: Oxycodone HCl Controlled-Release (Page 7 of 7)

General Advice About Oxycodone HCl Controlled-Release Tablets

  • Do not use Oxycodone HCl Controlled-Release Tablets for conditions for which it was not prescribed.
  • Do not give Oxycodone HCl Controlled-Release Tablets to other people, even if they have the same symptoms you have. Sharing is illegal and may cause severe medical problems, including death.

This leaflet summarizes the most important information about Oxycodone HCl Controlled-Release Tablets. If you would like more information, talk with your doctor. Also, you can ask your pharmacist or doctor for information about Oxycodone HCl Controlled-Release Tablets that is written for health professionals.

Rx Only

Distributed by:

Ranbaxy Pharmaceuticals Inc

Jacksonville, FL 32257 USA

302389-0A Rev 09/2009

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

this is the 10 mg container label
(click image for full-size original)

Container Label 10 mg

this is the 20 mg container label
(click image for full-size original)

Container Label 20 mg

OXYCODONE HCL CONTROLLED-RELEASE
oxycodone hcl controlled-release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-400
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE
SODIUM HYDROXIDE
SORBIC ACID
STEARYL ALCOHOL
TALC
TITANIUM DIOXIDE
TRIACETIN
HYDROXYPROPYL CELLULOSE
EUDRAGIT RS 30
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code OC;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-400-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020553 02/01/2010
OXYCODONE HCL CONTROLLED-RELEASE
oxycodone hcl controlled-release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-401
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE
SODIUM HYDROXIDE
SORBIC ACID
STEARYL ALCOHOL
TALC
TITANIUM DIOXIDE
TRIACETIN
POLYSORBATE 80
FERRIC OXIDE RED
EUDRAGIT RS 30
Product Characteristics
Color pink Score no score
Shape ROUND Size 7mm
Flavor Imprint Code OC;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-401-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020553 02/01/2010
Labeler — Ranbaxy Pharmaceuticals Inc (937890044)
Registrant — Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Operations
Purdue Pharmaceuticlas LP 132080875 manufacture
Establishment
Name Address ID/FEI Operations
Ranbaxy Pharmaceuticals Inc 937890044 relabel

Revised: 01/2010 Ranbaxy Pharmaceuticals Inc

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.