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 CII Initial U.S. Approval: 1950
Approved
Approval ID
d7dceba3-96dc-4593-bc8f-318052bdb520
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2022
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-403
Application NumberNDA201194
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2022
FDA Product Classification
INGREDIENTS (8)
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-401
Application NumberNDA201194
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2022
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT