Oxycodone and Acetaminophen

Product NDC
63187-721
11-digit product format
631870721
Labeler code
63187
Product ID
63187-721_b6da114d-fc88-4f72-9055-a963b4625f25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040778
Marketing category
ANDA
Marketing start
2007-11-27
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 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
63187-721-156318707211515 TABLET in 1 BOTTLE (63187-721-15) 15 tablet2016-06-01NoNoHistorical
63187-721-206318707212020 TABLET in 1 BOTTLE (63187-721-20) 20 tablet2016-06-01NoNoHistorical
63187-721-306318707213030 TABLET in 1 BOTTLE (63187-721-30) 30 tablet2016-06-01NoNoHistorical
63187-721-606318707216060 TABLET in 1 BOTTLE (63187-721-60) 60 tablet2016-06-01NoNoHistorical
63187-721-906318707219090 TABLET in 1 BOTTLE (63187-721-90) 90 tablet2017-05-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CIIProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL4