Oxycodone Hydrochloride

Product NDC
76420-761
11-digit product format
764200761
Labeler code
76420
Product ID
76420-761_2b35649b-3399-ef25-e063-6294a90a1efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA091490
Marketing category
ANDA
Marketing start
2014-09-08
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
76420-761-0176420076101100 TABLET in 1 BOTTLE, PLASTIC (76420-761-01) 100 tablet2025-01-08NoNoHistorical
76420-761-107642007611010 TABLET in 1 BOTTLE, PLASTIC (76420-761-10) 10 tablet2025-01-08NoNoHistorical
76420-761-207642007612020 TABLET in 1 BOTTLE, PLASTIC (76420-761-20) 20 tablet2025-01-08NoNoHistorical
76420-761-307642007613030 TABLET in 1 BOTTLE, PLASTIC (76420-761-30) 30 tablet2025-01-08NoNoHistorical
76420-761-607642007616060 TABLET in 1 BOTTLE, PLASTIC (76420-761-60) 60 tablet2025-01-08NoNoHistorical
76420-761-907642007619090 TABLET in 1 BOTTLE, PLASTIC (76420-761-90) 90 tablet2025-01-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone HydrochlorideAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-01-08HUMAN PRESCRIPTION DRUG LABEL1