Oxycodone and Acetaminophen

Product NDC
63629-1910
11-digit product format
636291910
Labeler code
63629
Product ID
63629-1910_218a2153-72e5-4f23-8c76-a95391a39550
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
63629-1910-1EA - Each63629-19101af293a3-4fd4-46fa-bbea-3d03e3d1b6c812021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1910-163629191001500 TABLET in 1 BOTTLE (63629-1910-1) 500 tablet2019-03-150000-00-00NoNoCurrent