NDC 63629-4174

Opana ER

Oxymorphone Hydrochloride

Opana ER is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Oxymorphone Hydrochloride.

Product ID63629-4174_b0d683e0-ee2e-4a82-8ae5-fec301c8167b
NDC63629-4174
Product TypeHuman Prescription Drug
Proprietary NameOpana ER
Generic NameOxymorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-12-31
Marketing CategoryNDA / NDA
Application NumberNDA021610
Labeler NameBryant Ranch Prepack
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-4174-1

60 TABLET in 1 BOTTLE (63629-4174-1)
Marketing Start Date2010-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4174-2 [63629417402]

Opana ER TABLET
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-31
Inactivation Date2019-11-27

NDC 63629-4174-4 [63629417404]

Opana ER TABLET
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-15
Inactivation Date2019-11-27

NDC 63629-4174-3 [63629417403]

Opana ER TABLET
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-31
Inactivation Date2019-11-27

NDC 63629-4174-1 [63629417401]

Opana ER TABLET
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:0ae0e103-5250-4745-8ae2-74fa47fbf973
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977904
  • 977902

    • 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 ER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OPANA ER
    OPANA ER
    85341864 4101723 Dead/Cancelled
    Endo Pharmaceuticals Inc.
    2011-06-09
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.