NDC 61919-615

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 ID61919-615_b8b62e6b-527f-18cf-e053-2a95a90a4111
NDC61919-615
Product TypeHuman Prescription Drug
Proprietary NameOXYCODONE APAP
Generic NameOxycodone Apap
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-02-23
Marketing CategoryANDA /
Application NumberANDA040778
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 61919-615-30

30 TABLET in 1 BOTTLE (61919-615-30)
Marketing Start Date2016-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-615-30 [61919061530]

OXYCODONE APAP TABLET
Marketing CategoryANDA
Application NumberANDA040778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-23
Marketing End Date2018-03-14

Drug Details

NDC Crossover Matching brand name "OXYCODONE APAP" or generic name "Oxycodone Apap"

NDCBrand NameGeneric Name
61919-412OXYCODONE APAPOXYCODONE APAP
61919-615OXYCODONE APAPOXYCODONE APAP

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