TARGINIQ
These highlights do not include all the information needed to use TARGINIQ™ ER safely and effectively. See full prescribing information for TARGINIQ ER. TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), for oral use, CIIInitial U.S. Approval: 2014
Approved
Approval ID
98e70c9c-fa3c-e63f-41d4-dac3c6fec51d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2016
Manufacturers
FDA
Purdue Pharma LP
DUNS: 932323652
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone hydrochloride/naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59011-521
Application NumberNDA205777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone hydrochloride/naloxone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (12)
OXYCODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
NALOXONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: F850569PQR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Oxycodone hydrochloride/naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59011-520
Application NumberNDA205777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone hydrochloride/naloxone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (11)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
NALOXONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: F850569PQR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
Oxycodone hydrochloride/naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59011-522
Application NumberNDA205777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone hydrochloride/naloxone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (12)
NALOXONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F850569PQR
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT