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Drug Product Composition: Duloxetine Hydrochloride

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$ API Ref.Price (USD/KG) : 277Xls

USFDA APPLICATION NUMBER - 21427 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Duloxetine hydrochloride (UNII: 9044SC542W)
(Duloxetine - UNII:O5TNM5N07U)
Duloxetine30mg | 60mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
BluePoint Laboratories
Bryant Ranch Prepack
Cadila Healthcare Limited
Cipla USA Inc.
Heritage Pharmaceuticals Inc.
Inventia Healthcare Private Limited
Preferred Pharmaceuticals Inc.
REMEDYREPACK INC.
Aurobindo Pharma Limited
Avera McKennan Hospital
AvPAK
Cardinal Health
Dr. Reddy's Laboratories Limited
KAISER FOUNDATION HOSPITALS
Lake Erie Medical DBA Quality Care Products LLC
LUPIN PHARMA
Lupin Pharmaceuticals, Inc.
Major Pharmaceuticals
Mylan Institutional Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
Prasco Laboratories
Preferred Pharmaceuticals, Inc.
Quality Care Products, LLC
Trigen Laboratories, LLC
QPharma Inc
Teva Pharmaceuticals USA, Inc.
NCS HealthCare of KY, LLC dba Vangard Labs
Torrent Pharmaceuticals Limited
TYA Pharmaceuticals
Unit Dose Services
Yaopharma Co., Ltd.
Clinical Solutions Wholesale
Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Proficient Rx LP
St Marys Medical Park Pharmacy
Yaopharma Co., L
ALCOHOL(3K9958V90M)                             
AMMONIA(5138Q19F1X)             
BUTYL ALCOHOL(8PJ61P6TS3)                             
CROSCARMELLOSE SODIUM(M28OL1HH48)                                 
CROSPOVIDONE (120 .MU.M)(68401960MK)                                     
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                 
CROSPOVIDONE(2S7830E561)                                     
CROSPOVIDONE(68401960MK)                               
D&C YELLOW NO. 10(35SW5USQ3G)                              
DIBUTYL SEBACATE(4W5IH7FLNY)                                
FD&C BLUE NO. 1(H3R47K3TBD)                      
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C GREEN NO. 3(3P3ONR6O1S)                                    
FD&C RED NO. 3(PN2ZH5LOQY)                                    
FD&C RED NO. 40(WZB9127XOA)                            
FD&C YELLOW NO. 6(H77VEI93A8)                                
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)            
GELATIN(2G86QN327L)          
GELATIN, UNSPECIFIED(2G86QN327L)                         
Glycine(TE7660XO1C)                                    
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                    
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                  
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)                                     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                 
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                     
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                   
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                                    
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                                    
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                         
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                       
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)(24P2YXD2PW)                          
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)                          
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)                      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                             
Hypromelloses(3NXW29V3WO)                      
ISOPROPYL ALCOHOL(ND2M416302)                             
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                               
MAGNESIUM STEARATE(70097M6I30)                                 
MANNITOL(3OWL53L36A)                                   
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                         
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)                                    
METHYLCELLULOSE (15 CPS)(NPU9M2E6L8)                                     
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8)                                
METHYLENE CHLORIDE(588X2YUY0A)                          
POLOXAMER 407(TUF2IVW3M2)                                
POLYETHYLENE GLYCOL 400(B697894SGQ)                             
POLYSORBATE 80(6OZP39ZG8H)                               
Polyvinyl Acetate Phthalate(58QVG85GW3)                                
Potassium hydroxide(WZH3C48M4T)              
POVIDONE K30(U725QWY32X)                                    
POVIDONE(FZ989GH94E)                                     
POVIDONE, UNSPECIFIED(FZ989GH94E)                                   
POVIDONES(FZ989GH94E)                                     
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)(9Q5W5G6461)                                 
PROPYLENE GLYCOL(6DC9Q167V3)           
SHELLAC(46N107B71O)           
SILICON DIOXIDE(ETJ7Z6XBU4)                                    
SODIUM HYDROXIDE(55X04QC32I)                               
SODIUM LAURYL SULFATE(368GB5141J)      
STARCH, CORN(O8232NY3SJ)                     
STARCH, PREGELATINIZED CORN(O8232NY3SJ)                                    
SUCROSE(C151H8M554)    
Talc(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIETHYL CITRATE(8Z96QXD6UM) 
WATER(059QF0KO0R)