NDC 63629-4177

OPANA ER

Oxymorphone Hydrochloride

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

Product ID63629-4177_b8bdd68c-ac5d-4244-b9d9-1818cafa9674
NDC63629-4177
Product TypeHuman Prescription Drug
Proprietary NameOPANA ER
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-06-30
Marketing CategoryNDA / NDA
Application NumberNDA021610
Labeler NameBryant Ranch Prepack
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-4177-3

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4177-3)
Marketing Start Date2006-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4177-2 [63629417702]

OPANA ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-30
Inactivation Date2019-11-27

NDC 63629-4177-3 [63629417703]

OPANA ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-30
Inactivation Date2019-11-27

NDC 63629-4177-1 [63629417701]

OPANA ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-30
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:5770c65f-dd52-4ba0-928e-495cfc12c587
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977915
  • 977917

    • 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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