NDC 55700-791

OXYCODONE HCl

Oxycodone Hcl

OXYCODONE HCl is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Oxycodone Hydrochloride.

Product ID55700-791_224b022c-de6e-49bf-a43b-ea4514612d98
NDC55700-791
Product TypeHuman Prescription Drug
Proprietary NameOXYCODONE HCl
Generic NameOxycodone Hcl
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-09-13
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022272
Labeler NameQuality Care Products, LLC
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55700-791-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-791-30)
Marketing Start Date2019-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-791-30 [55700079130]

OXYCODONE HCl TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022272
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:172dee35-aa29-4389-acc0-707305ee90b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860157
  • Pharmacological Class

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

    NDC Crossover Matching brand name "OXYCODONE HCl" or generic name "Oxycodone Hcl"

    NDCBrand NameGeneric Name
    10702-801OXYCODONE HClOXYCODONE HCl
    10702-803OXYCODONE HClOXYCODONE HCl
    10702-805OXYCODONE HClOXYCODONE HCl
    55700-791OXYCODONE HClOXYCODONE HCl
    61919-659Oxycodone HCLOxycodone HCL
    61919-671OXYCODONE HCLOXYCODONE HCL
    63304-683OXYCODONE HCloxycodone hydrochloride
    63304-684OXYCODONE HCloxycodone hydrochloride
    69238-2294Oxycodone HClOxycodone HCl
    69238-2296Oxycodone HClOxycodone HCl
    69238-2298Oxycodone HClOxycodone HCl
    69238-2300Oxycodone HClOxycodone HCl

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