NDC 13107-103

Oxymorphone Hydrochloride

Oxymorphone Hydrochloride

Oxymorphone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma, Llc. The primary component is Oxymorphone Hydrochloride.

Product ID13107-103_0d911015-d84b-4695-b2f7-a4033f7e9483
NDC13107-103
Product TypeHuman Prescription Drug
Proprietary NameOxymorphone Hydrochloride
Generic NameOxymorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA204459
Labeler NameAurolife Pharma, LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13107-103-01

100 TABLET in 1 BOTTLE (13107-103-01)
Marketing Start Date2016-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-103-30 [13107010330]

Oxymorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA204459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-26

NDC 13107-103-01 [13107010301]

Oxymorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA204459
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-26

NDC 13107-103-99 [13107010399]

Oxymorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA204459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-26

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:22c7652a-aa16-4fa8-89d9-517e69059068
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977942
  • 977939
  • Pharmacological Class

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

    Medicade Reported Pricing

    13107010301 OXYMORPHONE HCL 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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