Opana - 35356-820-30 - (oxymorphone hydrochloride)

Alphabetical Index


Drug Information of Opana

Product NDC: 35356-820
Proprietary Name: Opana
Non Proprietary Name: oxymorphone hydrochloride
Active Ingredient(s): 10    mg/1 & nbsp;   oxymorphone hydrochloride
Administration Route(s): ORAL
Dosage Form(s): TABLET, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Opana

Product NDC: 35356-820
Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA201655
Marketing Category: NDA
Start Marketing Date: 20120320

Package Information of Opana

Package NDC: 35356-820-30
Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-820-30)

NDC Information of Opana

NDC Code 35356-820-30
Proprietary Name Opana
Package Description 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-820-30)
Product NDC 35356-820
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name oxymorphone hydrochloride
Dosage Form Name TABLET, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20120320
Marketing Category Name NDA
Labeler Name Lake Erie Medical DBA Quality Care Products LLC
Substance Name OXYMORPHONE HYDROCHLORIDE
Strength Number 10
Strength Unit mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Opana


General Information