Oxycodone and Acetaminophen

Product NDC
71205-486
11-digit product format
712050486
Labeler code
71205
Product ID
71205-486_a41237cc-3ead-41aa-bde7-8bc0bb93eafd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
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
71205-486-307120504863030 TABLET in 1 BOTTLE (71205-486-30) 30 tablet2020-10-14NoNoHistorical
71205-486-607120504866060 TABLET in 1 BOTTLE (71205-486-60) 60 tablet2020-10-14NoNoHistorical
71205-486-907120504869090 TABLET in 1 BOTTLE (71205-486-90) 90 tablet2020-10-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx OnlyProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL2