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
bab5f88d-95e5-6e41-c800-4e3b85583d10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-010
Application NumberANDA205853
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (8)
Oxycodone HydrochlorideActive
Quantity: 100 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
Sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
Sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
D&C Yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT