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
6869fec9-1837-4221-afd8-5cc6fadd025d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Genus Lifesciences Inc.
DUNS: 113290444
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 Code64950-353
Application NumberNDA200535
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C Yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Oxycodone HydrochlorideActive
Quantity: 100 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-354
Application NumberNDA200535
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (8)
Oxycodone HydrochlorideActive
Quantity: 5 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C Red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT