Oxycodone Hydrochloride and Acetaminophen

Product NDC
60760-965
11-digit product format
607600965
Labeler code
60760
Product ID
60760-965_40a8831f-60ae-fa65-e063-6394a90ade4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA209385
Marketing category
ANDA
Marketing start
2017-12-04
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 mg/1; 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
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-965-606076009656060 TABLET in 1 BOTTLE, PLASTIC (60760-965-60) 60 tablet2025-10-07NoNoHistorical
60760-965-906076009659090 TABLET in 1 BOTTLE, PLASTIC (60760-965-90) 90 tablet2025-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CIIST. MARY'S MEDICAL PARK PHARMACY2025-10-08HUMAN PRESCRIPTION DRUG LABEL1