Oxycodone and Acetaminophen

Product NDC
63629-8879
11-digit product format
636298879
Labeler code
63629
Product ID
63629-8879_9fb7986f-172b-4e3a-a61d-94cca7b8b9ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8879OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]103Legacy NDC20240602_626b7834-edb8-4d13-af5c-fff97d4eb9de.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8879-16362988790130 TABLET in 1 BOTTLE, PLASTIC (63629-8879-1) 30 tablet2021-10-040000-00-00NoNoCurrent
63629-8879-26362988790290 TABLET in 1 BOTTLE, PLASTIC (63629-8879-2) 90 tablet2021-10-040000-00-00NoNoCurrent
63629-8879-36362988790360 TABLET in 1 BOTTLE, PLASTIC (63629-8879-3) 60 tablet2021-10-040000-00-00NoNoCurrent