OXYCODONE HYDROCHLORIDE

Product NDC
42858-010
11-digit product format
428580010
Labeler code
42858
Product ID
42858-010_fff8e4c0-4fbc-4469-89e0-10fe66722831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA205853
Marketing category
ANDA
Marketing start
2020-05-14
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
100 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42858-010-15428580010151 BOTTLE, PLASTIC in 1 CARTON (42858-010-15) > 30 mL in 1 BOTTLE, PLASTIC2020-05-140000-00-00NoNoCurrent