OPANA - 16590-765-28 - (OXYMORPHONE HYDROCHLORIDE)

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Drug Information of OPANA

Product NDC: 16590-765
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
Coding System: National Drug Codes(NDC)

Labeler Information of OPANA

Product NDC: 16590-765
Labeler Name: STAT Rx USA LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021611
Marketing Category: NDA
Start Marketing Date: 20111215

Package Information of OPANA

Package NDC: 16590-765-28
Package Description: 28 TABLET in 1 BOTTLE (16590-765-28)

NDC Information of OPANA

NDC Code 16590-765-28
Proprietary Name OPANA
Package Description 28 TABLET in 1 BOTTLE (16590-765-28)
Product NDC 16590-765
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name OXYMORPHONE HYDROCHLORIDE
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20111215
Marketing Category Name NDA
Labeler Name STAT Rx USA 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