Oxycodone Hydrochloride

Product NDC
68308-505
11-digit product format
683080505
Labeler code
68308
Product ID
68308-505_0289f8f5-2dae-441f-b4d6-15275b97f9fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA091313
Marketing category
ANDA
Marketing start
2011-02-28
Marketing end
2020-08-31
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record