OPANA ER - 21695-948-60 - (Oxymorphone Hydrochloride)

Alphabetical Index


Drug Information of OPANA ER

Product NDC: 21695-948
Proprietary Name: OPANA ER
Non Proprietary Name: Oxymorphone Hydrochloride
Active Ingredient(s): 5    mg/1 & nbsp;   Oxymorphone Hydrochloride
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of OPANA ER

Product NDC: 21695-948
Labeler Name: Rebel Distributors Corp
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021610
Marketing Category: NDA
Start Marketing Date: 20060622

Package Information of OPANA ER

Package NDC: 21695-948-60
Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-948-60)

NDC Information of OPANA ER

NDC Code 21695-948-60
Proprietary Name OPANA ER
Package Description 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-948-60)
Product NDC 21695-948
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Oxymorphone Hydrochloride
Dosage Form Name TABLET, FILM COATED, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20060622
Marketing Category Name NDA
Labeler Name Rebel Distributors Corp
Substance Name OXYMORPHONE HYDROCHLORIDE
Strength Number 5
Strength Unit mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of OPANA ER


General Information