Oxycodone HCL

Product NDC
72189-613
11-digit product format
721890613
Labeler code
72189
Product ID
72189-613_323148b2-809b-db11-e063-6294a90abe36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077712
Marketing category
ANDA
Marketing start
2025-04-07
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 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
72189-613-307218906133030 TABLET in 1 BOTTLE (72189-613-30) 30 tablet2025-04-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone HCLDirect_Rx2025-04-07HUMAN PRESCRIPTION DRUG LABEL1