NDC 63481-816

Opana ER

Oxymorphone Hydrochloride

Opana ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Oxymorphone Hydrochloride.

Product ID63481-816_78824d02-9c7b-45ce-8030-48bc1d817cc6
NDC63481-816
Product TypeHuman Prescription Drug
Proprietary NameOpana ER
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-03-20
Marketing End Date2019-08-01
Marketing CategoryNDA / NDA
Application NumberNDA201655
Labeler NameEndo Pharmaceuticals, Inc.
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 63481-816-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63481-816-60)
Marketing Start Date2012-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63481-816-70 [63481081670]

Opana ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA201655
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-20
Marketing End Date2012-03-20

NDC 63481-816-60 [63481081660]

Opana ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA201655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-20
Marketing End Date2019-08-01

NDC 63481-816-20 [63481081620]

Opana ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA201655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-20
Marketing End Date2014-10-31

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:e6e34c18-fbc6-4cab-9aed-0905d93c2ab6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977931
  • 977894
  • 977917
  • 977896
  • 977915
  • 977904
  • 977923
  • 977902
  • 977925
  • 977929
  • 977911
  • 977876
  • 977874
  • 977909
  • UPC Code
  • 0363481818602
  • 0363481817605
  • 0363481812600
  • 0363481814604
  • 0363481816608
  • 0363481815601
  • 0363481813607
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    Medicade Reported Pricing

    63481081660 OPANA ER 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    63481081620 OPANA ER 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Opana ER" or generic name "Oxymorphone Hydrochloride"

    NDCBrand NameGeneric Name
    21695-948OPANA EROPANA ER
    21695-949OPANA EROPANA ER
    35356-825Opana EROpana ER
    35356-848Opana EROpana ER
    35356-849Opana EROpana ER
    35356-820Opana EROpana ER
    63481-816Opana EROpana ER
    63481-817Opana EROpana ER
    63481-814Opana EROpana ER
    63481-815Opana EROpana ER
    63481-818Opana EROpana ER
    63481-812Opana EROpana ER
    63481-813Opana EROpana ER
    63629-4174Opana EROpana ER
    63629-4177OPANA EROPANA ER
    0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochloride
    0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochloride
    0115-1231Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1232Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1233Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1234Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1315Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1316Oxymorphone hydrochlorideOxymorphone hydrochloride
    0115-1317Oxymorphone hydrochlorideOxymorphone hydrochloride

    Trademark Results [Opana]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OPANA
    OPANA
    77471861 3553676 Dead/Cancelled
    Endo Pharmaceuticals Inc.
    2008-05-12
    OPANA
    OPANA
    77471835 3585918 Dead/Cancelled
    Endo Pharmaceuticals Inc.
    2008-05-12
    OPANA
    OPANA
    76665614 3252736 Dead/Cancelled
    Endo Pharmaceuticals Inc.
    2006-09-05
    OPANA
    OPANA
    76478457 3060635 Live/Registered
    Endo Pharmaceuticals Inc.
    2002-12-20

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