OXAYDO
These highlights do not include all the information needed to use OXAYDO safely and effectively. See full prescribing information for OXAYDO. OXAYDO (oxycodone HCl) tablets for oral use only – CII Initial U.S. Approval: 1950
Approved
Approval ID
cff0c64a-63f5-4b3c-909a-cdecf6755cbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Zyla Life Sciences US LLC
DUNS: 079581441
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 Code69344-213
Application NumberNDA202080
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2020
FDA Product Classification
INGREDIENTS (1)
OXYCODONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69344-113
Application NumberNDA202080
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2020
FDA Product Classification
INGREDIENTS (1)
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB