OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-2106
11-digit product format
713352106
Labeler code
71335
Product ID
71335-2106_3e2312f9-2b0c-4137-88e2-5c75c659a6d0
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; 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
71335-2106-17133521060130 TABLET in 1 BOTTLE (71335-2106-1) 30 tablet2022-07-05NoNoHistorical
71335-2106-271335210602120 TABLET in 1 BOTTLE (71335-2106-2) 120 tablet2024-05-31NoNoHistorical
71335-2106-37133521060390 TABLET in 1 BOTTLE (71335-2106-3) 90 tablet2022-07-11NoNoHistorical
71335-2106-47133521060428 TABLET in 1 BOTTLE (71335-2106-4) 28 tablet2024-05-31NoNoHistorical
71335-2106-57133521060560 TABLET in 1 BOTTLE (71335-2106-5) 60 tablet2022-06-10NoNoHistorical
71335-2106-67133521060620 TABLET in 1 BOTTLE (71335-2106-6) 20 tablet2024-05-31NoNoHistorical
71335-2106-77133521060745 TABLET in 1 BOTTLE (71335-2106-7) 45 tablet2024-05-31NoNoHistorical
71335-2106-87133521060875 TABLET in 1 BOTTLE (71335-2106-8) 75 tablet2024-05-31NoNoHistorical
71335-2106-971335210609100 TABLET in 1 BOTTLE (71335-2106-9) 100 tablet2024-05-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx onlyBryant Ranch Prepack2024-05-31HUMAN PRESCRIPTION DRUG LABEL104