Oxycodone and Acetaminophen

Product NDC
60760-897
11-digit product format
607600897
Labeler code
60760
Product ID
60760-897_3cd1ca9c-719a-6e6d-e063-6294a90a1537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202677
Marketing category
ANDA
Marketing start
2016-03-09
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 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
60760-897-306076008973030 TABLET in 1 BOTTLE, PLASTIC (60760-897-30) 30 tablet2025-08-20NoNoHistorical
60760-897-606076008976060 TABLET in 1 BOTTLE, PLASTIC (60760-897-60) 60 tablet2025-08-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx OnlyST. MARY'S MEDICAL PARK PHARMACY2025-08-20HUMAN PRESCRIPTION DRUG LABEL1