ENDOCET

Product NDC
63629-2190
11-digit product format
636292190
Labeler code
63629
Product ID
63629-2190_3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040330
Marketing category
ANDA
Marketing start
2003-03-06
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-2190-163629219001100 TABLET in 1 BOTTLE, PLASTIC (63629-2190-1) 100 tablet2024-08-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Bryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL103