OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-2041
11-digit product format
713352041
Labeler code
71335
Product ID
71335-2041_ff73dc7b-b171-41a0-8bdb-cafd25f64309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
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
71335-2041-07133520410025 TABLET in 1 BOTTLE (71335-2041-0) 25 tablet2024-05-31NoNoHistorical
71335-2041-17133520410110 TABLET in 1 BOTTLE (71335-2041-1) 10 tablet2022-03-14NoNoHistorical
71335-2041-271335204102120 TABLET in 1 BOTTLE (71335-2041-2) 120 tablet2022-02-01NoNoHistorical
71335-2041-37133520410328 TABLET in 1 BOTTLE (71335-2041-3) 28 tablet2024-05-31NoNoHistorical
71335-2041-47133520410412 TABLET in 1 BOTTLE (71335-2041-4) 12 tablet2024-05-31NoNoHistorical
71335-2041-57133520410540 TABLET in 1 BOTTLE (71335-2041-5) 40 tablet2022-03-16NoNoHistorical
71335-2041-67133520410630 TABLET in 1 BOTTLE (71335-2041-6) 30 tablet2022-02-18NoNoHistorical
71335-2041-77133520410790 TABLET in 1 BOTTLE (71335-2041-7) 90 tablet2022-02-10NoNoHistorical
71335-2041-87133520410860 TABLET in 1 BOTTLE (71335-2041-8) 60 tablet2022-05-09NoNoHistorical
71335-2041-97133520410984 TABLET in 1 BOTTLE (71335-2041-9) 84 tablet2024-05-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx onlyBryant Ranch Prepack2024-05-31HUMAN PRESCRIPTION DRUG LABEL103