Oxycodone Hydrochloride
These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. Oxycodone Hydrochloride oral solution, CIIInitial U.S. Approval: 1950
Approved
Approval ID
7c686a46-1f5f-46e3-945b-2ade3931718f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2021
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone Hydrochloride
PRODUCT DETAILS
NDC Product Code66689-025
Application NumberANDA202537
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 19, 2021
Generic NameOxycodone Hydrochloride
INGREDIENTS (6)
OXYCODONE HYDROCHLORIDEActive
Quantity: 100 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT