Oxycodone Hydrochloride

Product NDC
76420-757
11-digit product format
764200757
Labeler code
76420
Product ID
76420-757_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
10 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
76420-757-0176420075701100 TABLET in 1 BOTTLE, PLASTIC (76420-757-01) 100 tablet2024-01-08NoNoHistorical
76420-757-107642007571010 TABLET in 1 BOTTLE, PLASTIC (76420-757-10) 10 tablet2024-01-08NoNoHistorical
76420-757-207642007572020 TABLET in 1 BOTTLE, PLASTIC (76420-757-20) 20 tablet2024-01-08NoNoHistorical
76420-757-307642007573030 TABLET in 1 BOTTLE, PLASTIC (76420-757-30) 30 tablet2024-01-08NoNoHistorical
76420-757-607642007576060 TABLET in 1 BOTTLE, PLASTIC (76420-757-60) 60 tablet2024-01-08NoNoHistorical
76420-757-907642007579090 TABLET in 1 BOTTLE, PLASTIC (76420-757-90) 90 tablet2024-01-08NoNoHistorical

Related DailyMed Labels

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