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Drug Product Composition: Acesistem

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$ API Ref.Price (USD/KG) : 35Xls

USFDA APPLICATION NUMBER - 19129 / DOSAGE - TABLET;ORAL - 25MG;37.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
HYDROCHLOROTHIAZIDE25mg
TRIAMTERENE(UNII: WS821Z52LQ)
(TRIAMTERENE - UNII:WS821Z52LQ)
TRIAMTERENE37.5mg

Inactive Ingredients

Ingredient Name
REMEDYREPACK INC.
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Sandoz Inc
St Marys Medical Park Pharmacy
Unit Dose Services
A-S Medication Solutions LLC
AvKARE, Inc.
BluePoint Laboratories
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
A-S Medication Solutions
Aphena Pharma Solutions - Tennessee, LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc
ALUMINUM OXIDE(LMI26O6933)                  
ANHYDROUS LACTOSE(3SY5LH9PMK)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
CROSCARMELLOSE SODIUM(M28OL1HH48)       
D&C YELLOW NO. 10(35SW5USQ3G)    
FD&C BLUE NO. 1(H3R47K3TBD)     
FD&C BLUE NO. 2(L06K8R7DQK)              
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)             
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)          
POLACRILIN POTASSIUM(0BZ5A00FQU)              
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)              
POLYSORBATE 80(6OZP39ZG8H)            
POVIDONE(FZ989GH94E)                
POVIDONE, UNSPECIFIED(FZ989GH94E)                  
POVIDONES(FZ989GH94E)                  
POWDERED CELLULOSE(SMD1X3XO9M)           
SILICON DIOXIDE(ETJ7Z6XBU4)         
SODIUM BICARBONATE(8MDF5V39QO)            
SODIUM LAURYL SULFATE(368GB5141J)           
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)