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Drug Product Composition: Didral

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

USFDA APPLICATION NUMBER - 20758 / DOSAGE - TABLET;ORAL - 12.5MG;300MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydrochlorothiazide(UNII: 0J48LPH2TH)
(hydrochlorothiazide - UNII:0J48LPH2TH)
hydrochlorothiazide12.5mg | 12.5mg
irbesartan(UNII: J0E2756Z7N)
(irbesartan - UNII:J0E2756Z7N)
irbesartan300mg | 150mg

Inactive Ingredients

Ingredient Name
Apotex Corp.
NuCare Pharmaceuticals, Inc.
REMEDYREPACK INC.
Cardinal Health
Legacy Pharmaceutical Packaging
Mylan Pharmaceuticals Inc.
AvKARE, Inc.
Proficient Rx LP
Qualitest Pharmaceuticals
Unichem Pharmaceuticals (USA), Inc.
Lupin Pharmaceuticals, Inc.
Rising Pharmaceuticals, Inc.
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)           
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)          
carnauba wax(R12CBM0EIZ)           
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)        
croscarmellose sodium(M28OL1HH48)    
CROSPOVIDONE(2S7830E561)           
CROSPOVIDONE(68401960MK)           
D&C YELLOW NO. 10(35SW5USQ3G)           
FERRIC OXIDE RED(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)        
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)           
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)          
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)           
HYPROMELLOSES(3NXW29V3WO)           
LACTOSE MONOHYDRATE(EWQ57Q8I5X)      
LECITHIN, SOYBEAN(1DI56QDM62)           
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)          
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)         
POLOXAMER 188(LQA7B6G8JG)       
POLYETHYLENE GLYCOL 3000(SA1B764746)         
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)         
POLYETHYLENE GLYCOL 400(B697894SGQ)          
POLYETHYLENE GLYCOL 6000(30IQX730WE)          
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)           
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)           
POVIDONE K25(K0KQV10C35)           
POVIDONE K29/32(390RMW2PEQ)         
POVIDONE K30(U725QWY32X)       
POVIDONE(FZ989GH94E)           
POVIDONES(FZ989GH94E)           
PROPYLENE GLYCOL(6DC9Q167V3)           
SHELLAC(46N107B71O)           
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE(368GB5141J)           
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)         
SODIUM STEARYL FUMARATE(7CV7WJK4UI)           
STARCH, CORN(O8232NY3SJ)       
TALC(7SEV7J4R1U)        
TITANIUM DIOXIDE(15FIX9V2JP)