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Drug Product Composition: Bupropion Hydrochloride

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

USFDA APPLICATION NUMBER - 21515 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bupropion hydrochloride(UNII: ZG7E5POY8O)
(bupropion - UNII:01ZG3TPX31)
bupropion hydrochloride150mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
American Health Packaging
AvKARE
AvPAK
BluePoint Laboratories
Bryant Ranch Prepack
Cardinal Health
Granules Pharmaceuticals Inc.
Lake Erie Medical DBA Quality Care Products LLC
NCS HealthCare of KY, Inc dba Vangard Labs
Par Pharmaceutical, Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
Biocon Pharma Inc.,
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Graviti Pharmaceuticals Private Limited
Jubilant Cadista Pharmaceuticals Inc.
Lannett Company Inc.
Lupin Pharmaceuticals, Inc.
Method Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
Quallent Pharmaceuticals Health LLC
Rising Pharma Holdings, Inc.
Sandoz Inc.
Wockhardt Limited
Wockhardt USA LLC.
Amneal Pharmaceuticals of New York LLC
Golden State Medical Supply
St Marys Medical Park Pharmacy
NCS HealthCare of KY, LLC dba Vangard Labs
Actavis Pharma, Inc.
McKesson Packaging Services a Business unit of McKesson Corporation
Proficient Rx LP
REMEDYREPACK INC.
Unit Dose Services
Westminster Pharmaceuticals, LLC
Slate Run Pharmaceuticals, LLC
Aphena Pharma Solutions - Tennessee, LLC
Golden State Medical Supply, Inc.
McKesson Corporation DBA SKY Packaging
PD-Rx Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc.
Bausch Health US LLC
Sun Pharmaceutical Industries, Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Par Phar
Preferred Pharmaceutical
ALCOHOL(3K9958V90M)                                      
AMMONIA(5138Q19F1X)                                 
AMMONIUM CHLORIDE(01Q9PC255D)                                                 
Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer(7K68DGG29P)                                                  
BUTYL ALCOHOL(8PJ61P6TS3)                                             
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                                         
CITRIC ACID MONOHYDRATE(2968PHW8QP)                                              
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                                  
COPOVIDONE K25-31(D9C330MD8B)                                       
COPOVIDONE(D9C330MD8B)                                               
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                                 
Cysteine Hydrochloride(ZT934N0X4W)                                        
DIBUTYL SEBACATE(4W5IH7FLNY)                                          
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)                                      
ETHYLCELLULOSE (45 MPA.S)(V7AD894FAZ)                                                  
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                                      
ETHYLCELLULOSES(7Z8S9VYZ4B)                             
FD&C RED NO. 40(WZB9127XOA)                                            
FD&C YELLOW NO. 5(I753WB2F1M)                                            
FERRIC OXIDE RED(1K09F3G675)                                                
FERROSOFERRIC OXIDE(XM0M87F357)                    
glyceryl behenate(R8WTH25YS2)                                                  
GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR)                                          
GLYCERYL DIBEHENATE(R8WTH25YS2)                            
GLYCERYL DISTEARATE(73071MW2KM)                                               
HYDRATED SILICA(Y6O7T4G8P9)                                                
HYDROCHLORIC ACID(QTT17582CB)                          
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)                                        
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)                                                  
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                              
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                        
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                               
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)                                             
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                      
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                                           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                                    
HYPROMELLOSES(3NXW29V3WO)                                              
ISOPROPYL ALCOHOL(ND2M416302)                                    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                                           
LECITHIN, SOYBEAN(1DI56QDM62)                                                 
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)                                                
MAGNESIUM STEARATE(70097M6I30)                      
MANNITOL(3OWL53L36A)                                                 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)                                                  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)                                           
METHACRYLIC ACID(1CS02G8656)                                      
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                                         
METHYLENE CHLORIDE(588X2YUY0A)                                              
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                                         
POLYCARBOPHIL(W25LM17A4W)                                                  
POLYDEXTROSE(VH2XOU12IE)                                            
POLYETHYLENE GLYCOL 1450(OJ4Z5Z32L4)                                         
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                                                
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                                  
Polyethylene Glycol, Unspecified(3WJQ0SDW1A)                                  
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                        
POLYSORBATE 80(6OZP39ZG8H)                                                 
POLYVINYL ALCOHOL(532B59J990)                                       
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                                 
POVIDONE K90(RDH86HJV5Z)                                           
POVIDONE(FZ989GH94E)                                 
POVIDONE, UNSPECIFIED(FZ989GH94E)                             
POVIDONES(FZ989GH94E)                                          
PROPYLENE GLYCOL(6DC9Q167V3)                     
PVP/VA COPOLYMER(D9C330MD8B)                                                  
SHELLAC(46N107B71O)                             
SILICA DIMETHYL SILYLATE(EU2PSP0G0W)                                          
SILICON DIOXIDE(ETJ7Z6XBU4)                   
SODIUM BICARBONATE(8MDF5V39QO)                                    
SODIUM LAURYL SULFATE(368GB5141J)                                    
Sodium Stearyl Fumarate(7CV7WJK4UI)                                                  
STEARIC ACID(4ELV7Z65AP)                                         
TALC(7SEV7J4R1U)                        
TARTARIC ACID(W4888I119H)                                               
TITANIUM DIOXIDE(15FIX9V2JP)                         
TRIACETIN(XHX3C3X673)                                         
TRICETIN(5627PY99ZO)                                                  
TRIETHYL CITRATE(8Z96QXD6UM)                     
WATER(059QF0KO0R)