NDC 55700-788

Oxymorphone hydrochloride

Oxymorphone Hydrochloride

Oxymorphone hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Oxymorphone Hydrochloride.

Product ID55700-788_1dd752f7-eb2e-4395-a646-418939def683
NDC55700-788
Product TypeHuman Prescription Drug
Proprietary NameOxymorphone hydrochloride
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA079087
Labeler NameQuality Care Products, LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55700-788-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-788-60)
Marketing Start Date2021-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-788-60 [55700078860]

Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079087
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-30
Marketing End Date2020-02-26

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:fe6eea77-a178-4df0-b93c-e5c07457d69f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977874

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    10702-071Oxymorphone HydrochlorideOxymorphone Hydrochloride
    10702-070Oxymorphone HydrochlorideOxymorphone Hydrochloride
    13107-103Oxymorphone HydrochlorideOxymorphone Hydrochloride
    13107-104Oxymorphone HydrochlorideOxymorphone Hydrochloride
    31722-929OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
    31722-930OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
    35356-968Oxymorphone HydrochlorideOxymorphone Hydrochloride
    35356-967Oxymorphone HydrochlorideOxymorphone Hydrochloride
    55700-387Oxymorphone hydrochlorideOxymorphone hydrochloride
    55700-215Oxymorphone hydrochlorideOxymorphone hydrochloride
    55700-417Oxymorphone hydrochlorideOxymorphone hydrochloride
    55700-423Oxymorphone hydrochlorideOxymorphone hydrochloride
    60951-794Oxymorphone HydrochlorideOxymorphone Hydrochloride
    60951-795Oxymorphone HydrochlorideOxymorphone Hydrochloride
    63304-224Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-221Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-222Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-218Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-219Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-220Oxymorphone hydrochlorideOxymorphone hydrochloride
    63304-223Oxymorphone hydrochlorideOxymorphone hydrochloride
    0406-1010OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
    0406-1009OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
    42806-331Oxymorphone HydrochlorideOxymorphone Hydrochloride
    42806-330Oxymorphone HydrochlorideOxymorphone Hydrochloride
    64896-700Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-701Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-695Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-699Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-698Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-696Oxymorphone hydrochlorideOxymorphone hydrochloride
    64896-697Oxymorphone hydrochlorideOxymorphone hydrochloride
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