OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-2049
11-digit product format
713352049
Labeler code
71335
Product ID
71335-2049_0528bfb6-38fa-448e-a709-859515405822
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207510
Marketing category
ANDA
Marketing start
2019-06-01
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
71335-2049-17133520490130 TABLET in 1 BOTTLE (71335-2049-1) 30 tablet2022-02-28NoNoHistorical
71335-2049-271335204902120 TABLET in 1 BOTTLE (71335-2049-2) 120 tablet2022-02-28NoNoHistorical
71335-2049-37133520490390 TABLET in 1 BOTTLE (71335-2049-3) 90 tablet2022-02-28NoNoHistorical
71335-2049-47133520490428 TABLET in 1 BOTTLE (71335-2049-4) 28 tablet2022-02-28NoNoHistorical
71335-2049-57133520490560 TABLET in 1 BOTTLE (71335-2049-5) 60 tablet2022-02-28NoNoHistorical
71335-2049-67133520490620 TABLET in 1 BOTTLE (71335-2049-6) 20 tablet2022-02-28NoNoHistorical
71335-2049-77133520490745 TABLET in 1 BOTTLE (71335-2049-7) 45 tablet2022-02-28NoNoHistorical
71335-2049-87133520490875 TABLET in 1 BOTTLE (71335-2049-8) 75 tablet2022-02-28NoNoHistorical
71335-2049-971335204909100 TABLET in 1 BOTTLE (71335-2049-9) 100 tablet2022-02-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN - Bryant Ranch PrepackBryant Ranch Prepack2024-05-23HUMAN PRESCRIPTION DRUG LABEL102