NDC 0115-1231

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 Amneal Pharmaceuticals Of New York Llc. The primary component is Oxymorphone Hydrochloride.

Product ID0115-1231_2fc5d9a0-616b-44f3-9371-d68a7a911cda
NDC0115-1231
Product TypeHuman Prescription Drug
Proprietary NameOxymorphone hydrochloride
Generic NameOxymorphone Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-01-02
Marketing CategoryANDA / ANDA
Application NumberANDA079087
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0115-1231-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-01)
Marketing Start Date2013-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1231-08 [00115123108]

Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079087
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-02
Inactivation Date2020-01-31

NDC 0115-1231-03 [00115123103]

Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079087
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-02
Inactivation Date2020-01-31

NDC 0115-1231-13 [00115123113]

Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079087
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-02
Inactivation Date2020-01-31

NDC 0115-1231-01 [00115123101]

Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079087
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:557e9610-62d7-42bf-90c1-44215bd8c1f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977894
  • 977915
  • 977923
  • 977902
  • 977929
  • 977874
  • 977909
    • UPC Code
  • 0301151316010
  • 0301151315013
  • 0301151231016
  • 0301151317017
  • 0301151233010
  • 0301151234017
  • 0301151232013

    • 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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