OXYCODONE APAP

Product NDC
61919-615
11-digit product format
619190615
Labeler code
61919
Product ID
61919-615_b8b62e6b-527f-18cf-e053-2a95a90a4111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE APAP
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040778
Marketing category
ANDA
Marketing start
2016-02-23
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-615-306191906153030 TABLET in 1 BOTTLE (61919-615-30) 30 tablet2016-02-230000-00-00NoNoCurrent