Oxycodone and Acetaminophen

Product NDC
71335-1472
11-digit product format
713351472
Labeler code
71335
Product ID
71335-1472_e1b4a30f-f119-4b26-bec2-4c72c917d9bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1472-07133514720084 TABLET in 1 BOTTLE (71335-1472-0) 84 tablet2024-04-03NoNoHistorical
71335-1472-171335147201120 TABLET in 1 BOTTLE (71335-1472-1) 120 tablet2020-06-23NoNoHistorical
71335-1472-27133514720290 TABLET in 1 BOTTLE (71335-1472-2) 90 tablet2020-03-31NoNoHistorical
71335-1472-37133514720360 TABLET in 1 BOTTLE, PLASTIC (71335-1472-3) 60 tablet2020-02-28NoNoHistorical
71335-1472-47133514720430 TABLET in 1 BOTTLE (71335-1472-4) 30 tablet2020-02-14NoNoHistorical
71335-1472-571335147205100 TABLET in 1 BOTTLE (71335-1472-5) 100 tablet2024-04-03NoNoHistorical
71335-1472-67133514720645 TABLET in 1 BOTTLE (71335-1472-6) 45 tablet2020-06-22NoNoHistorical
71335-1472-77133514720728 TABLET in 1 BOTTLE (71335-1472-7) 28 tablet2024-04-03NoNoHistorical
71335-1472-871335147208168 TABLET in 1 BOTTLE (71335-1472-8) 168 tablet2024-04-03NoNoHistorical
71335-1472-97133514720920 TABLET in 1 BOTTLE (71335-1472-9) 20 tablet2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 mg*/325 mg, 7.5 mg*/325 mg, 10 mg*/325 mg CIIBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL103