NDC 0115-1561

OXYCODONE HYDROCHLORIDE

Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Oxycodone Hydrochloride.

Product ID0115-1561_8d745b1a-1fec-405f-a12f-482e5634252b
NDC0115-1561
Product TypeHuman Prescription Drug
Proprietary NameOXYCODONE HYDROCHLORIDE
Generic NameOxycodone Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-02-22
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022272
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0115-1561-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1561-01)
Marketing Start Date2016-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1561-01 [00115156101]

OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022272
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-22

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860148
  • 1860151
  • 1860157
  • 1860154
  • 1860129
  • 1860127
  • 1860137
  • UPC Code
  • 0301151557017
  • 0301151558014
  • 0301151559011
  • 0301151560017
  • 0301151562011
  • 0301151556010
  • 0301151561014
  • Pharmacological Class

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