OXYCODONE AND ACETAMINOPHEN

Product NDC
71335-1959
11-digit product format
713351959
Labeler code
71335
Product ID
71335-1959_6eeeb7dc-4dfc-4cb4-99cf-ffcee9112f00
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; 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

openFDA Listing Details

Product ID
71335-1959_6eeeb7dc-4dfc-4cb4-99cf-ffcee9112f00
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
OXYCODONE AND ACETAMINOPHEN
Generic name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Marketing start
2017-04-11
Marketing category
ANDA
Application number
ANDA207419
Pharmacologic classes
Full Opioid Agonists [MoA]; Opioid Agonist [EPC]
DEA schedule
CII
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1
OXYCODONE HYDROCHLORIDE7.5 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii362O9ITL9D, C1ENJ2TE6C
Rxcui1049225
Spl Set Id88d05136-7b04-4b25-af1c-6bc72fdbcbd7
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1959-17133519590121 TABLET in 1 BOTTLE (71335-1959-1) 21 tablet2024-05-310000-00-00NoNoCurrent
71335-1959-27133519590236 TABLET in 1 BOTTLE (71335-1959-2) 36 tablet2021-09-300000-00-00NoNoCurrent
71335-1959-37133519590320 TABLET in 1 BOTTLE (71335-1959-3) 20 tablet2024-05-310000-00-00NoNoCurrent
71335-1959-47133519590430 TABLET in 1 BOTTLE (71335-1959-4) 30 tablet2021-10-260000-00-00NoNoCurrent
71335-1959-57133519590545 TABLET in 1 BOTTLE (71335-1959-5) 45 tablet2024-05-310000-00-00NoNoCurrent
71335-1959-67133519590660 TABLET in 1 BOTTLE (71335-1959-6) 60 tablet2021-10-070000-00-00NoNoCurrent
71335-1959-77133519590790 TABLET in 1 BOTTLE (71335-1959-7) 90 tablet2021-10-260000-00-00NoNoCurrent
71335-1959-871335195908120 TABLET in 1 BOTTLE (71335-1959-8) 120 tablet2021-11-100000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx onlyBryant Ranch Prepack2024-05-31HUMAN PRESCRIPTION DRUG LABEL103