Oxycodone and Acetaminophen

Product NDC
60760-898
11-digit product format
607600898
Labeler code
60760
Product ID
60760-898_3cd2e544-a0c1-4f62-e063-6294a90a1583
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 7.5 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
60760-898-306076008983030 TABLET in 1 BOTTLE, PLASTIC (60760-898-30) 30 tablet2025-08-21NoNoHistorical
60760-898-606076008986060 TABLET in 1 BOTTLE, PLASTIC (60760-898-60) 60 tablet2025-08-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 mg*/325 mg, 7.5 mg*/325 mg, 10 mg*/325 mg CIIST. MARY'S MEDICAL PARK PHARMACY2025-08-20HUMAN PRESCRIPTION DRUG LABEL1