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
06af7dff-c261-4c03-9cd9-0605c42507fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc
DUNS: 826774775
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 Code31722-929
Application NumberANDA210175
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (5)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-930
Application NumberANDA210175
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (6)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT