ENDOCET

Product NDC
63629-2188
11-digit product format
636292188
Labeler code
63629
Product ID
63629-2188_2067f977-defb-4eaf-b100-19b166658de8
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
2000-05-26
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
63629-2188-163629218801100 TABLET in 1 BOTTLE (63629-2188-1) 100 tablet2000-05-26NoNoHistorical

Related DailyMed Labels

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