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Drug Product Composition: Amitriptyline Hydrochloride

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$ API Ref.Price (USD/KG) : 63Xls

USFDA APPLICATION NUMBER - 85968 / DOSAGE - TABLET;ORAL - 75MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K)
AMITRIPTYLINE HYDROCHLORIDE50mg

Inactive Ingredients

Ingredient Name
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
A-S Medication Solutions LLC
American Health Packaging
Avera McKennan Hospital
Blenheim Pharmacal, Inc.
Bryant Ranch Prepack
Clinical Solutions Wholesale
DIRECT RX
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical, Inc.
PD-Rx Pharmaceuticals, Inc.
RedPharm Drug, Inc.
REMEDYREPACK INC.
St. Mary's Medical Park Pharmacy
STAT RX USA LLC
TYA Pharmaceuticals
Unit Dose Services
A-S Medication Solutions
Preferred Pharamaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Sandoz Inc
Cardinal Health
Direct Rx
CALCIUM SULFATE, UNSPECIFIED FORM(WAT0DDB505)                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)        
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                          
CROSCARMELLOSE SODIUM(M28OL1HH48)                    
D&C RED NO. 27(2LRS185U6K)                         
D&C RED NO. 30(2S42T2808B)                     
D&C RED NO. 33(9DBA0SBB0L)                     
D&C RED NO. 7(ECW0LZ41X8)                           
D&C YELLOW NO. 10(35SW5USQ3G)          
FD&C BLUE NO. 1(H3R47K3TBD)            
FD&C BLUE NO. 2(L06K8R7DQK)           
FD&C RED NO. 40(WZB9127XOA)            
FD&C Yellow No. 6(H77VEI93A8)               
FERRIC OXIDE RED(1K09F3G675)            
FERRIC OXIDE YELLOW(EX438O2MRT)                  
FERROSOFERRIC OXIDE(XM0M87F357)                  
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                           
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                         
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                         
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                        
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                        
HYPROMELLOSE(3NXW29V3WO)                          
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                    
HYPROMELLOSES(3NXW29V3WO)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
LECITHIN, SOYBEAN(1DI56QDM62)                    
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                  
POLYETHYLENE GLYCOL 400(B697894SGQ)                           
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)              
POLYSORBATE 80(6OZP39ZG8H)            
POLYVINYL ALCOHOL(532B59J990)                        
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                        
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE(368GB5141J)                     
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)        
STARCH, CORN(O8232NY3SJ)              
TALC(7SEV7J4R1U)                  
Titanium Dioxide(15FIX9V2JP) 
XANTHAN GUM(TTV12P4NEE)