Oxymorphone Hydrochloride
These highlights do not include all the information needed to use Oxymorphone Hydrochloride safely and effectively. see full prescribing information for Oxymorphone Hydrochloride. Oxymorphone Hydrochloride (Oxymorphone Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 1959
Approved
Approval ID
82cc28da-27d1-4d29-83ab-e6719e49750d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
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 Code35356-967
Application NumberANDA203601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Oxymorphone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35356-968
Application NumberANDA203601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (5)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT