OXYCODONE HYDROCHLORIDE

Product NDC
68071-3600
11-digit product format
680713600
Labeler code
68071
Product ID
68071-3600_17f796b6-3f89-c988-e063-6394a90a7cb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091393
Marketing category
ANDA
Marketing start
2013-10-18
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3600-4680713600044 TABLET in 1 BOTTLE (68071-3600-4) 4 tablet2024-05-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.2024-05-08HUMAN PRESCRIPTION DRUG LABEL1