Oxycodone Hydrochloride

Product NDC
67296-2188
11-digit product format
672962188
Labeler code
67296
Product ID
67296-2188_44f3146e-88e3-80e1-e063-6394a90a3a28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA077712
Marketing category
ANDA
Marketing start
2024-09-10
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
67296-2188-16729621880112 TABLET in 1 BOTTLE, PLASTIC (67296-2188-1) 12 tablet2024-09-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone HydrochlorideRedpharm Drug2025-12-02HUMAN PRESCRIPTION DRUG LABEL2