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
c801963d-f54d-4ed5-82c4-8b278528d3dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2021
Manufacturers
FDA
Eywa Pharma Inc
DUNS: 080465609
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 Code71930-023
Application NumberANDA209897
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2021
Generic NameOxycodone hydrochloride
INGREDIENTS (9)
OXYCODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: C1ENJ2TE6C
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
BERRYInactive
Code: FV3431923Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT