OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-9675
11-digit product format
713359675
Labeler code
71335
Product ID
71335-9675_3765101e-9311-474e-89eb-9e208c671c5a
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; 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
71335-9675-17133596750121 TABLET in 1 BOTTLE (71335-9675-1) 21 tablet2023-03-27NoNoHistorical
71335-9675-27133596750236 TABLET in 1 BOTTLE (71335-9675-2) 36 tablet2023-03-27NoNoHistorical
71335-9675-37133596750320 TABLET in 1 BOTTLE (71335-9675-3) 20 tablet2023-03-27NoNoHistorical
71335-9675-47133596750430 TABLET in 1 BOTTLE (71335-9675-4) 30 tablet2023-03-27NoNoHistorical
71335-9675-57133596750545 TABLET in 1 BOTTLE (71335-9675-5) 45 tablet2023-03-27NoNoHistorical
71335-9675-67133596750660 TABLET in 1 BOTTLE (71335-9675-6) 60 tablet2023-03-27NoNoHistorical
71335-9675-77133596750790 TABLET in 1 BOTTLE (71335-9675-7) 90 tablet2023-03-27NoNoHistorical
71335-9675-871335967508120 TABLET in 1 BOTTLE (71335-9675-8) 120 tablet2023-03-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN - Bryant Ranch PrepackBryant Ranch Prepack2023-03-27HUMAN PRESCRIPTION DRUG LABEL100