NDC 64896-701

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 Llc. The primary component is Oxymorphone Hydrochloride.

Product ID64896-701_80c97af6-7ccb-4296-99d2-170f301c6e61
NDC64896-701
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 LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64896-701-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-01)
Marketing Start Date2013-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64896-701-08 [64896070108]

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

NDC 64896-701-03 [64896070103]

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

NDC 64896-701-01 [64896070101]

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

NDC 64896-701-13 [64896070113]

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

Drug Details

Active Ingredients

IngredientStrength
OXYMORPHONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:3f4e703a-e398-42fd-8759-e398c79955f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977894
  • 977915
  • 977923
  • 977902
  • 977929
  • 977874
  • 977909
  • UPC Code
  • 0364896695017
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.