NDC 23635-580

Roxicodone

Oxycodone Hydrochloride

Roxicodone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Oxycodone Hydrochloride.

Product ID23635-580_94133522-0ad0-4e5d-a95d-4874b5476c1a
NDC23635-580
Product TypeHuman Prescription Drug
Proprietary NameRoxicodone
Generic NameOxycodone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-08-26
Marketing CategoryNDA / NDA
Application NumberNDA021011
Labeler NameSpecGx LLC
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 23635-580-10

100 TABLET in 1 BOTTLE, PLASTIC (23635-580-10)
Marketing Start Date2000-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23635-580-10 [23635058010]

Roxicodone TABLET
Marketing CategoryNDA
Application NumberNDA021011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-08-31

NDC 23635-580-25 [23635058025]

Roxicodone TABLET
Marketing CategoryNDA
Application NumberNDA021011
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-08-31

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:5a8157d3-ba20-4abf-b0d4-6ad141b31d63
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049621
  • 1049620
  • 1049623
  • 1049618
  • 1049611
  • 1049613
    • UPC Code
  • 0323635580106
  • 0323635582100
  • 0323635581103

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Roxicodone" or generic name "Oxycodone Hydrochloride"

    NDCBrand NameGeneric Name
    23635-580RoxicodoneRoxicodone
    23635-581RoxicodoneRoxicodone
    23635-582RoxicodoneRoxicodone
    0054-0390oxycodone hydrochlorideoxycodone hydrochloride
    0054-0393Oxycodone HydrochlorideOxycodone Hydrochloride
    0054-0522Oxycodone HydrochlorideOxycodone Hydrochloride
    0093-5731Oxycodone HydrochlorideOxycodone Hydrochloride
    0093-5732Oxycodone HydrochlorideOxycodone Hydrochloride
    0093-5733Oxycodone HydrochlorideOxycodone Hydrochloride
    0093-5734Oxycodone HydrochlorideOxycodone Hydrochloride
    0115-1556OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    0115-1557OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    0115-1558OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    0115-1559OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

    Trademark Results [Roxicodone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROXICODONE
    ROXICODONE
    76404992 not registered Dead/Abandoned
    AAIPHARMA, INC.
    2002-05-08
    ROXICODONE
    ROXICODONE
    76401917 2686302 Live/Registered
    SPECGX LLC
    2002-04-24
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