OXYMORPHONE HYDROCHLORIDE

Product NDC
63629-1926
11-digit product format
636291926
Labeler code
63629
Product ID
63629-1926_c58a9e13-1792-4569-a677-28d9aaf0c9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210175
Marketing category
ANDA
Marketing start
2018-03-01
Substance
OXYMORPHONE 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
5Y2EI94NBCOXYMORPHONE HYDROCHLORIDE357-07-3OXYMORPHONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-1926-163629192601100 TABLET in 1 BOTTLE (63629-1926-1) 100 tablet2021-01-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYMORPHONE HYDROCHLORIDEBryant Ranch Prepack2024-01-09HUMAN PRESCRIPTION DRUG LABEL102