OXYMORPHONE HYDROCHLORIDE
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets, for Oral use CII Initial U.S. Approval: 1959
Approved
Approval ID
1a1d5061-b62a-49fa-a5b2-4970f51416ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2020
Manufacturers
FDA
XLCare Pharmaceuticals, Inc.
DUNS: 080991142
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXYMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-130
Application NumberANDA210175
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-131
Application NumberANDA210175
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB