OXYCODONE HYDROCHLORIDE
These highlights do not include all the information needed to use OXYCODONE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl EXTENDED-RELEASE TABLETS. OXYCODONE HCl EXTENDED-RELEASE TABLETS, for oral use, CIIInitial U.S. Approval: 1950
Approved
Approval ID
c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 7
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 Code0115-1561
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1557
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1559
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1562
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (10)
OXYCODONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1560
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (9)
OXYCODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1558
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (9)
OXYCODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
OXYCODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1556
Application NumberNDA022272
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (8)
OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT