NUCYNTA
These highlights do not include all the information needed to use NUCYNTA safely and effectively. See full prescribing information for NUCYNTA. NUCYNTA (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008
Approved
Approval ID
ba3db17e-5697-46f0-8fb3-dd19e93e1a08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TAPENTADOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-889
Application NumberNDA022304
Product Classification
M
Marketing Category
C73594
G
Generic Name
TAPENTADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
FDA Product Classification
INGREDIENTS (11)
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TAPENTADOL HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 71204KII53
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT