NDC 72189-375

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 Acetaminophen; Oxycodone Hydrochloride.

Product ID72189-375_e84245ca-9580-e85b-e053-2a95a90a836b
NDC72189-375
Product TypeHuman Prescription Drug
Proprietary NameOxycodone/APAP
Generic NameOxycodone/apap
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-09-09
Marketing CategoryANDA /
Application NumberANDA201278
Labeler NameDirect_Rx
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72189-375-60

60 TABLET in 1 BOTTLE (72189-375-60)
Marketing Start Date2022-09-09
NDC Exclude FlagN
Sample Package?N

Drug Details

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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