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Drug Product Composition: Lansoprazole Hoechst Brand

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$ API Ref.Price (USD/KG) : 93Xls

USFDA APPLICATION NUMBER - 20406 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lansoprazole(UNII: 0K5C5T2QPG)
(lansoprazole - UNII:0K5C5T2QPG)
lansoprazole30mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
ACTAVIS PHARMA, INC.
Breckenridge Pharmaceutical, Inc.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Lake Erie Medical DBA Quality Care Products LLC
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
Apace Packaging, LLC
AvKARE, Inc
AvPAK
Bryant Ranch Prepack
Direct RX
Lannett Company, Inc..
Preferred Pharmaceuticals Inc.
Quality Care Products, LLC
Sun Pharma Global FZE
Sun Pharmaceutical Industries Limited
American Health Packaging
NuCare Pharmaceuticals, Inc.
Sandoz Inc
REMEDYREPACK INC.
Wockhardt Limited
Wockhardt USA LLC.
AvKARE, Inc.
Physicians Total Care, Inc.
DirectRx
Direct_Rx
Lifestar Pharma LLC.
NuCare Pharmaceuticals,Inc.
DIRECT RX
Proficient Rx LP
Rebel Distributors Corp
Unit Dose Services
ACETONE(1364PS73AF)                          
ALCOHOL(3K9958V90M)                     
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL(PGG6VG42HP)                              
AMMONIA(5138Q19F1X)               
BUTYL ALCOHOL(8PJ61P6TS3)                     
CARNAUBA WAX(R12CBM0EIZ)                               
CARRAGEENAN(5C69YCD2YJ)                               
D&C RED NO. 28(767IP0Y5NH)                    
D&C RED NO. 33(9DBA0SBB0L)                             
D&C YELLOW NO. 10(35SW5USQ3G)                              
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)                    
FERRIC OXIDE RED(1K09F3G675)                    
FERRIC OXIDE YELLOW(EX438O2MRT)                    
FERROSOFERRIC OXIDE(XM0M87F357)        
GELATIN(2G86QN327L)          
GELATIN, UNSPECIFIED(2G86QN327L)                       
GLYCERYL 1-OLEATE(D3AEF6S35P)                               
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, LOW SUBSTITUTED(2165RE0K14)                      
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                              
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                          
HYPROMELLOSES(3NXW29V3WO)                        
ISOPROPYL ALCOHOL(ND2M416302)                
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)                            
MAGNESIUM CARBONATE(0E53J927NA)  
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)                               
POLYETHYLENE GLYCOL 400(B697894SGQ)                        
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                          
POLYETHYLENE GLYCOL 6000(30IQX730WE)                       
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                          
polyethylene glycols(3WJQ0SDW1A)                          
polysorbate 80(6OZP39ZG8H)        
POTASSIUM CHLORIDE(660YQ98I10)                               
POTASSIUM HYDROXIDE(WZH3C48M4T)             
PROPYLENE GLYCOL(6DC9Q167V3)           
raw sugar(8M707QY5GH)                           
SHELLAC(46N107B71O)      
SILICON DIOXIDE(ETJ7Z6XBU4)                         
SODIUM LAURYL SULFATE(368GB5141J)                      
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)                              
STARCH, CORN(O8232NY3SJ)     
SUCROSE(C151H8M554)     
SUGARCANE(81H2R5AOH3)                              
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)  
TRIETHYL CITRATE(8Z96QXD6UM)                           
WATER(059QF0KO0R)