OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-9674
11-digit product format
713359674
Labeler code
71335
Product ID
71335-9674_2b832254-e7b8-4d1a-9775-cdcffce01451
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; 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
71335-9674-07133596740025 TABLET in 1 BOTTLE (71335-9674-0) 25 tablet2023-03-27NoNoHistorical
71335-9674-17133596740110 TABLET in 1 BOTTLE (71335-9674-1) 10 tablet2023-03-27NoNoHistorical
71335-9674-271335967402120 TABLET in 1 BOTTLE (71335-9674-2) 120 tablet2023-03-27NoNoHistorical
71335-9674-37133596740328 TABLET in 1 BOTTLE (71335-9674-3) 28 tablet2023-03-27NoNoHistorical
71335-9674-47133596740412 TABLET in 1 BOTTLE (71335-9674-4) 12 tablet2023-03-27NoNoHistorical
71335-9674-57133596740540 TABLET in 1 BOTTLE (71335-9674-5) 40 tablet2023-03-27NoNoHistorical
71335-9674-67133596740630 TABLET in 1 BOTTLE (71335-9674-6) 30 tablet2023-03-27NoNoHistorical
71335-9674-77133596740790 TABLET in 1 BOTTLE (71335-9674-7) 90 tablet2023-03-27NoNoHistorical
71335-9674-87133596740860 TABLET in 1 BOTTLE (71335-9674-8) 60 tablet2023-03-27NoNoHistorical
71335-9674-97133596740984 TABLET in 1 BOTTLE (71335-9674-9) 84 tablet2023-03-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN - Bryant Ranch PrepackBryant Ranch Prepack2023-11-27HUMAN PRESCRIPTION DRUG LABEL101