NDC 58177-681

oxycodone hydrochloride controlled-release

Oxycodone Hydrochloride

oxycodone hydrochloride controlled-release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ethex Corporation. The primary component is Oxycodone Hydrochloride.

Product ID58177-681_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62
NDC58177-681
Product TypeHuman Prescription Drug
Proprietary Nameoxycodone hydrochloride controlled-release
Generic NameOxycodone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-09-25
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020553
Labeler NameEthex Corporation
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58177-681-04

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58177-681-04)
Marketing Start Date2009-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58177-681-04 [58177068104]

oxycodone hydrochloride controlled-release TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA020553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-25
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:f06d3690-3fd4-407d-8f8d-ab0c354e61bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049502
  • 1049599
  • 1049584
  • 1049563

    • Pharmacological Class

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

    NDC Crossover Matching brand name "oxycodone hydrochloride controlled-release" or generic name "Oxycodone Hydrochloride"

    NDCBrand NameGeneric Name
    58177-683oxycodone hydrochloride controlled-releaseoxycodone hydrochloride controlled-release
    58177-679oxycodone hydrochloride controlled-releaseoxycodone hydrochloride controlled-release
    58177-681oxycodone hydrochloride controlled-releaseoxycodone hydrochloride controlled-release
    58177-677oxycodone hydrochloride controlled-releaseoxycodone hydrochloride controlled-release
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.