NDC 35356-825

Opana ER

Oxymorphone Hydrochloride

Opana ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Oxymorphone Hydrochloride.

Product ID35356-825_c0d14e51-b521-45ca-af3f-667af6f27f23
NDC35356-825
Product TypeHuman Prescription Drug
Proprietary NameOpana ER
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-03-20
Marketing CategoryNDA / NDA
Application NumberNDA201655
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-825-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-825-60)
Marketing Start Date2012-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-825-60 [35356082560]

Opana ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA201655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-20
Marketing End Date2019-10-11

NDC 35356-825-30 [35356082530]

Opana ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA201655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-20
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:c9c381b4-94d1-4294-aa37-1a5a5423812d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977917
  • 977915
  • 977904
  • 977902
  • 977911
  • 977876
  • 977874
  • 977909

    • Pharmacological Class

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

    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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