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Drug Product Composition: Pantoprazole Sodium Sesquihydrate

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$ API Ref.Price (USD/KG) : 140Xls

USFDA APPLICATION NUMBER - 20987 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM(UNII: 6871619Q5X)
(PANTOPRAZOLE - UNII:D8TST4O562)
PANTOPRAZOLE40mg

Inactive Ingredients

Ingredient Name
Cardinal Health
Legacy Pharmaceutical Packaging
Macleods Pharmaceuticals Limited
Major Pharmaceuticals
AvKARE, Inc.
Bryant Ranch Prepack
Clinical Solutions Wholesale, LLC
DIRECT RX
Lake Erie Medical DBA Quality Care Products LLC
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
Physicians Total Care, Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
Rebel Distributors Corp
REMEDYREPACK INC.
RxChange Co.
Actavis Inc.
Avera McKennan Hospital
Clinical Solutions Wholesale
NuCare Pharmaceuticals, Inc.
OrchidPharma Inc
PD-Rx Pharmaceuticals, Inc.
Prasco Laboratories
Safecor Health, LLC
Sun Pharma Global FZE
Sun Pharmaceutical Industries Limited
Unit Dose Services
Wockhardt USA LLC.
Aphena Pharma Solutions - Tennessee, LLC
Contract Pharmacy Services-PA
NuCare Pharmaceuticals,Inc.
QPharma Inc
Teva Pharmaceuticals USA, Inc.
A-S Medication Solutions
Cardinal Health 107, LLC
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Direct_Rx
Preferred Pharmaceuticals Inc.
Proficient Rx
St Marys Medical Park Pharmacy
St. Mary's Medical Park Pharmacy
State of Florida DOH Central Pharmacy
Sun
Legacy Pharmaceutical Packaging, LLC
NCS HealthCare of KY, LLC dba Vangard Labs
Torrent Pharmaceuticals Limited
Aphena Pharma Solutions - Tennessee, Inc.
REMEDYREPACK INC.
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
Teva Pharmaceuticals USA
Teva Pharmaceuti
St Marys Medical Park Pharma
Teva Pharm
S
St. Mary's Medical
Safe
ALCOHOL(3K9958V90M)                                                     
ALUMINUM OXIDE(LMI26O6933)                                            
AMMONIA(5138Q19F1X)                                       
ANHYDROUS LACTOSE(3SY5LH9PMK)                                                   
BUTYL ALCOHOL(8PJ61P6TS3)                                           
CALCIUM CARBONATE(H0G9379FGK)                                       
CALCIUM STEARATE(776XM7047L)                  
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                                              
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                                       
CROSPOVIDONE (120 .MU.M)(68401960MK)                                                      
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                                  
CROSPOVIDONE (19 MPA.S AT 5%)(6B46OH7T95)                                                        
CROSPOVIDONE(2S7830E561)                                            
CROSPOVIDONE(68401960MK)                                     
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                                  
D&C YELLOW NO. 10(35SW5USQ3G)                                       
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)                                                     
FD&C BLUE NO. 2(L06K8R7DQK)                                                   
FD&C YELLOW NO. 6(H77VEI93A8)                                       
FERRIC OXIDE RED(1K09F3G675)                                             
FERRIC OXIDE YELLOW(EX438O2MRT)                    
FERROSOFERRIC OXIDE(XM0M87F357)                    
GLYCERYL DIBEHENATE(R8WTH25YS2)                                                
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                                     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                             
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)                                                       
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)                                                      
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)                                                        
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                                
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)                                                        
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                                        
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)                                              
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                                      
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                                                  
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, UNSPECIFIED(3NXW29V3WO)                                                 
HYPROMELLOSES(3NXW29V3WO)                                      
ISOBUTYL ALCOHOL(56F9Z98TEM)                                                        
ISOPROPYL ALCOHOL(ND2M416302)                                      
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                                 
LECITHIN, SOYBEAN(1DI56QDM62)                                                        
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)                                                
MANNITOL(3OWL53L36A)                      
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (NX76LV5T8J)                                                        
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)                                                     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                                                
POLYETHYLENE GLYCOL 400(B697894SGQ)                                              
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                                       
POLYETHYLENE GLYCOL 6000(30IQX730WE)                                                    
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                                        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                                                       
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                                   
POLYSORBATE 80(6OZP39ZG8H)                                               
POVIDONE K25(K0KQV10C35)                                                  
POVIDONE K90(RDH86HJV5Z)                                                  
POVIDONE(FZ989GH94E)                                                   
POVIDONE, UNSPECIFIED(FZ989GH94E)                                                      
POVIDONES(FZ989GH94E)                                                       
PROPYLENE GLYCOL(6DC9Q167V3)                   
SHELLAC(46N107B71O)                      
SILICON DIOXIDE(ETJ7Z6XBU4)                                                    
SODIUM CARBONATE(45P3261C7T)                                                       
SODIUM CARBONATE DECAHYDRATE(LS505BG22I)                                        
SODIUM CARBONATE(45P3261C7T)                   
SODIUM HYDROXIDE(55X04QC32I)                                                   
SODIUM LAURYL SULFATE(368GB5141J)                                             
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                                                 
STARCH, CORN(O8232NY3SJ)                                                   
STEARIC ACID(4ELV7Z65AP)                                       
Sucrose(C151H8M554)                                                      
TALC(7SEV7J4R1U)                    
TITANIUM DIOXIDE(15FIX9V2JP)                    
TRIETHYL CITRATE(8Z96QXD6UM)                   
ZEIN(80N308T1NN)