NDC 0054-0522

Oxycodone Hydrochloride

Oxycodone Hydrochloride

Oxycodone Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Roxane Laboratories, Inc.. The primary component is Oxycodone Hydrochloride.

Product ID0054-0522_db08764a-b691-4275-83d0-7dfd79e4896e
NDC0054-0522
Product TypeHuman Prescription Drug
Proprietary NameOxycodone Hydrochloride
Generic NameOxycodone Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA203208
Labeler NameRoxane Laboratories, Inc.
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength100 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC SPL Data Element Entries

NDC 0054-0522-44 [00054052244]

Oxycodone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA203208
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-07-16
Marketing End Date2017-09-11

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE100 mg/5mL

OpenFDA Data

SPL SET ID:75a36759-c970-4689-b373-a6a15b6a1a3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049615
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68084-184Oxycodone HydrochlorideOxycodone Hydrochloride
    68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68084-185Oxycodone HydrochlorideOxycodone Hydrochloride
    68094-801Oxycodone HydrochlorideOxycodone Hydrochloride
    68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68084-828Oxycodone HydrochlorideOxycodone Hydrochloride
    68084-048Oxycodone HydrochlorideOxycodone Hydrochloride
    68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68094-005Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-108Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-020Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-505Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-120Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-111Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-145Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-110Oxycodone HydrochlorideOxycodone Hydrochloride
    68308-112Oxycodone HydrochlorideOxycodone Hydrochloride
    68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    68462-204Oxycodone HydrochlorideOxycodone Hydrochloride
    68462-347Oxycodone HydrochlorideOxycodone Hydrochloride
    0527-1774Oxycodone HydrochlorideOxycodone Hydrochloride
    0527-1426Oxycodone HydrochlorideOxycodone Hydrochloride
    70166-492Oxycodone HydrochlorideOxycodone Hydrochloride
    0591-2693Oxycodone HydrochlorideOxycodone Hydrochloride
    0591-2708Oxycodone HydrochlorideOxycodone Hydrochloride
    0603-4991Oxycodone HydrochlorideOxycodone Hydrochloride
    0603-4992Oxycodone HydrochlorideOxycodone Hydrochloride
    0603-4994Oxycodone HydrochlorideOxycodone Hydrochloride
    0603-4990Oxycodone HydrochlorideOxycodone Hydrochloride
    0603-4993Oxycodone HydrochlorideOxycodone Hydrochloride
    71335-0677Oxycodone HydrochlorideOxycodone Hydrochloride
    71335-0174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
    71335-1023Oxycodone HydrochlorideOxycodone Hydrochloride
    71335-0209OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

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