XTAMPZA
These highlights do not include all the information needed to use XTAMPZA ER safely and effectively. See full prescribing information for XTAMPZA ER. XTAMPZA ER (oxycodone) extended-release capsules, for oral use, CII Initial U.S. Approval: 1950
Approved
Approval ID
b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Collegium Pharmaceutical, Inc.
DUNS: 032531241
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXYCODONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-120
Application NumberNDA208090
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (11)
OXYCODONEActive
Quantity: 18 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OXYCODONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-110
Application NumberNDA208090
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (11)
OXYCODONEActive
Quantity: 9 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXYCODONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-115
Application NumberNDA208090
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (11)
OXYCODONEActive
Quantity: 13.5 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXYCODONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-140
Application NumberNDA208090
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (11)
OXYCODONEActive
Quantity: 36 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXYCODONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24510-130
Application NumberNDA208090
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYCODONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (11)
OXYCODONEActive
Quantity: 27 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT