NDC 61919-524

OXYCODONE/APAP

Oxycodone/apap

OXYCODONE/APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID61919-524_86e366de-fa6b-89ae-e053-2a91aa0a2fed
NDC61919-524
Product TypeHuman Prescription Drug
Proprietary NameOXYCODONE/APAP
Generic NameOxycodone/apap
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-19
Marketing CategoryANDA / ANDA
Application NumberANDA201972
Labeler NameDirectRX
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-524-90

90 TABLET in 1 BOTTLE (61919-524-90)
Marketing Start Date2019-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-524-90 [61919052490]

OXYCODONE/APAP TABLET
Marketing CategoryANDA
Application NumberANDA201972
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-19

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:86e366de-fa6a-89ae-e053-2a91aa0a2fed
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "OXYCODONE/APAP" or generic name "Oxycodone/apap"

NDCBrand NameGeneric Name
61919-432OXYCODONE/APAPOXYCODONE/APAP
61919-524OXYCODONE/APAPOXYCODONE/APAP
61919-835Oxycodone/APAPOxycodone/APAP
72189-375Oxycodone/APAPOxycodone/APAP
72189-397PercocetOxycodone/APAP
72189-398PercocetOxycodone/APAP
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