OXYCODONE AND ACETAMINOPHEN

Product NDC
72189-256
11-digit product format
721890256
Labeler code
72189
Product ID
72189-256_36d68732-0635-1380-e063-6394a90a69c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA207510
Marketing category
ANDA
Marketing start
2021-08-10
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
72189-256-307218902563030 TABLET in 1 BOTTLE (72189-256-30) 30 tablet2021-08-10NoNoHistorical
72189-256-607218902566060 TABLET in 1 BOTTLE (72189-256-60) 60 tablet2021-08-10NoNoHistorical
72189-256-7272189025672120 TABLET in 1 BOTTLE (72189-256-72) 120 tablet2021-08-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONEDIRECT RX2025-06-05HUMAN PRESCRIPTION DRUG LABEL10