Oxycodone and Acetaminophen

Product NDC
71335-1909
11-digit product format
713351909
Labeler code
71335
Product ID
71335-1909_d5f709f5-ebb6-4ebc-a3d0-99463aaa8e0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
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
2027-12-31
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
71335-1909-17133519090121 TABLET in 1 BOTTLE, PLASTIC (71335-1909-1) 21 tablet2026-05-15NoNoHistorical
71335-1909-27133519090236 TABLET in 1 BOTTLE, PLASTIC (71335-1909-2) 36 tablet2026-05-15NoNoHistorical
71335-1909-37133519090320 TABLET in 1 BOTTLE, PLASTIC (71335-1909-3) 20 tablet2026-05-15NoNoHistorical
71335-1909-47133519090430 TABLET in 1 BOTTLE, PLASTIC (71335-1909-4) 30 tablet2022-11-08NoNoHistorical
71335-1909-57133519090545 TABLET in 1 BOTTLE, PLASTIC (71335-1909-5) 45 tablet2026-05-15NoNoHistorical
71335-1909-67133519090660 TABLET in 1 BOTTLE, PLASTIC (71335-1909-6) 60 tablet2026-05-15NoNoHistorical
71335-1909-77133519090790 TABLET in 1 BOTTLE, PLASTIC (71335-1909-7) 90 tablet2026-05-15NoNoHistorical
71335-1909-871335190908120 TABLET in 1 BOTTLE, PLASTIC (71335-1909-8) 120 tablet2022-11-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 mg*/325 mg, 7.5 mg*/325 mg, 10 mg*/325 mg CIIBryant Ranch Prepack2026-05-15HUMAN PRESCRIPTION DRUG LABEL104