NDC 63481-613

OPANA

Oxymorphone Hydrochloride

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

Product ID63481-613_14241cb2-6da3-45fe-8c75-f53717b57e13
NDC63481-613
Product TypeHuman Prescription Drug
Proprietary NameOPANA
Generic NameOxymorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-06-26
Marketing CategoryNDA / NDA
Application NumberNDA021611
Labeler NameEndo Pharmaceuticals, Inc.
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63481-613-70

100 TABLET in 1 BOTTLE (63481-613-70)
Marketing Start Date2006-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63481-613-75 [63481061375]

OPANA TABLET
Marketing CategoryNDA
Application NumberNDA021611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-26
Marketing End Date2010-04-20

NDC 63481-613-70 [63481061370]

OPANA TABLET
Marketing CategoryNDA
Application NumberNDA021611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-06-26
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:10d4a5d9-9cb8-4dcf-9836-34c377990128
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977942
  • 977943
  • 977940
  • 977939
    • UPC Code
  • 0363481623701

    • Pharmacological Class

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

    NDC Crossover Matching brand name "OPANA" or generic name "Oxymorphone Hydrochloride"

    NDCBrand NameGeneric Name
    63481-612OPANAOPANA
    63481-613OPANAOPANA
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.