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Drug Product Composition: Hydrochlorothiazide

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

USFDA APPLICATION NUMBER - 12616 / DOSAGE - TABLET;ORAL - 25MG;25MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydrochlorothiazide(UNII: 0J48LPH2TH)
(hydrochlorothiazide - UNII:0J48LPH2TH)
hydrochlorothiazide25mg
spironolactone(UNII: 27O7W4T232)
(spironolactone - UNII:27O7W4T232)
spironolactone25mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Mylan Pharmaceuticals Inc.
A-S Medication Solutions LLC
Pfizer Laboratories Div Pfizer Inc
Mylan Institutional Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)   
calcium sulfate(WAT0DDB505)    
CALCIUM SULFATE, UNSPECIFIED FORM(WAT0DDB505)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSCARMELLOSE SODIUM(M28OL1HH48)    
D&C YELLOW NO. 10(35SW5USQ3G)  
DOCUSATE SODIUM(F05Q2T2JA0)    
FD&C YELLOW NO. 6(H77VEI93A8)  
FERRIC OXIDE RED(1K09F3G675)   
hydroxypropyl cellulose(RFW2ET671P)    
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)    
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
hypromelloses(3NXW29V3WO)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)   
MAGNESIUM STEARATE(70097M6I30)
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)   
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
PEPPERMINT OIL(AV092KU4JH)   
PEPPERMINT(V95R5KMY2B)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
polyethylene glycols(3WJQ0SDW1A)    
povidone(FZ989GH94E)    
POVIDONE, UNSPECIFIED(FZ989GH94E)    
POVIDONES(FZ989GH94E)    
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM BENZOATE(OJ245FE5EU)    
SODIUM LAURYL SULFATE(368GB5141J)   
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)  
STARCH, CORN(O8232NY3SJ) 
titanium dioxide(15FIX9V2JP)