Oxycodone and Acetaminophen

Product NDC
71205-329
11-digit product format
712050329
Labeler code
71205
Product ID
71205-329_12b8ef8f-90ab-4366-9a82-e6164926eb84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
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
71205-329-107120503291010 TABLET in 1 BOTTLE (71205-329-10) 10 tablet2019-12-23NoNoHistorical
71205-329-287120503292828 TABLET in 1 BOTTLE (71205-329-28) 28 tablet2022-08-29NoNoHistorical
71205-329-307120503293030 TABLET in 1 BOTTLE (71205-329-30) 30 tablet2019-09-01NoNoHistorical
71205-329-607120503296060 TABLET in 1 BOTTLE (71205-329-60) 60 tablet2019-09-01NoNoHistorical
71205-329-907120503299090 TABLET in 1 BOTTLE (71205-329-90) 90 tablet2019-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP CII Rx OnlyProficient Rx LP2022-08-01HUMAN PRESCRIPTION DRUG LABEL4