NDC 61919-835

Oxycodone/APAP

Oxycodone/apap

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

Product ID61919-835_8c3b715b-4553-fb38-e053-2995a90a3d42
NDC61919-835
Product TypeHuman Prescription Drug
Proprietary NameOxycodone/APAP
Generic NameOxycodone/apap
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA207419
Labeler NameDirect_Rx
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-835-30

30 TABLET in 1 BOTTLE (61919-835-30)
Marketing Start Date2019-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-835-30 [61919083530]

Oxycodone/APAP TABLET
Marketing CategoryANDA
Application NumberANDA207419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-26

NDC 61919-835-60 [61919083560]

Oxycodone/APAP TABLET
Marketing CategoryANDA
Application NumberANDA207419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-26

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:8c3b715b-4552-fb38-e053-2995a90a3d42
Manufacturer
UNII

Pharmacological Class

  • 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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