OXYCODONE HYDROCHLORIDE

Product NDC
0406-8520
11-digit product format
004068520
Labeler code
0406
Product ID
0406-8520_d2534006-67e9-4e2a-a4f8-1e44d5857af5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076758
Marketing category
ANDA
Marketing start
2021-10-12
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
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
0406-8520-0100406852001100 TABLET in 1 BOTTLE (0406-8520-01) 100 tablet2021-10-12NoNoHistorical
0406-8520-23004068520231 TABLET in 1 BLISTER PACK (0406-8520-23) 1 tablet2021-10-12NoNoHistorical
0406-8520-6200406852062100 TABLET in 1 BLISTER PACK (0406-8520-62) 100 tablet2021-10-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE HYDROCHLORIDESpecGx LLC2024-01-01HUMAN PRESCRIPTION DRUG LABEL35
OXYCODONE HYDROCHLORIDESpecGx LLC2024-01-01HUMAN PRESCRIPTION DRUG LABEL34