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Drug Product Composition: Tapentadol Hydrochloride

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$ API Ref.Price (USD/KG) : 520Xls

USFDA APPLICATION NUMBER - 200533 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tapentadol hydrochloride(UNII: 71204KII53)
(tapentadol - UNII:H8A007M585)
tapentadol100mg

Inactive Ingredients

Ingredient Name
Janssen Pharmaceuticals, Inc.
Lake Erie Medical DBA Quality Care Products LLC
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
.ALPHA.-TOCOPHEROL(H4N855PNZ1) 
ALUMINUM OXIDE(LMI26O6933) 
FD&C BLUE NO. 2(L06K8R7DQK) 
ferric oxide yellow(EX438O2MRT) 
ferrosoferric oxide(XM0M87F357) 
HYPROMELLOSE, UNSPECIFIED (3NXW29V3WO)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)  
hypromelloses(3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) 
polyethylene glycols(3WJQ0SDW1A)  
polyvinyl alcohol(532B59J990)  
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) 
PROPYLENE GLYCOL (6DC9Q167V3)  
propylene glycol(6DC9Q167V3) 
SHELLAC (46N107B71O)  
SHELLAC(46N107B71O) 
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE (15FIX9V2JP)  
titanium dioxide(15FIX9V2JP)