NDC 21695-949

OPANA ER

Oxymorphone Hydrochloride

OPANA ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Oxymorphone Hydrochloride.

Product ID21695-949_b639732f-8eb2-4592-aca3-86faf7e5360b
NDC21695-949
Product TypeHuman Prescription Drug
Proprietary NameOPANA ER
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-06-22
Marketing CategoryNDA / NDA
Application NumberNDA021610
Labeler NameRebel Distributors Corp
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-949-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-949-60)
Marketing Start Date2006-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-949-60 [21695094960]

OPANA ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-22
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:b639732f-8eb2-4592-aca3-86faf7e5360b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977923
  • 977876
  • 977925
  • 977874

    • 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
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