OXYCODONE HYDROCHLORIDE

Product NDC
72189-095
11-digit product format
721890095
Labeler code
72189
Product ID
72189-095_36d68732-0635-1380-e063-6394a90a69c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204021
Marketing category
ANDA
Marketing start
2020-06-15
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-095-307218900953030 TABLET in 1 BOTTLE (72189-095-30) 30 tablet2020-06-15NoNoHistorical
72189-095-607218900956060 TABLET in 1 BOTTLE (72189-095-60) 60 tablet2020-06-15NoNoHistorical
72189-095-907218900959090 TABLET in 1 BOTTLE (72189-095-90) 90 tablet2020-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONEDIRECT RX2025-06-05HUMAN PRESCRIPTION DRUG LABEL10