Oxycodone and Acetaminophen

Product NDC
63629-1912
11-digit product format
636291912
Labeler code
63629
Product ID
63629-1912_62adecba-5c95-456d-94a4-d0baa3ae5aff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1912-1EA - Each63629-19126824bf9d-8dca-4903-8f12-0d07048fd11612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1912OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]104Legacy NDC20240502_5513980d-69e8-4f12-b881-56f2d80db951.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1912-163629191201500 TABLET in 1 BOTTLE (63629-1912-1) 500 tablet2019-03-150000-00-00NoNoCurrent