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Drug Product Composition: Amlodipine Besylate

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$ API Ref.Price (USD/KG) : 117Xls

USFDA APPLICATION NUMBER - 22314 / DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE5mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
HYDROCHLOROTHIAZIDE25mg
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I)
VALSARTAN160mg

Inactive Ingredients

Ingredient Name
Teva Pharmaceuticals USA, Inc.
Lupin Pharmaceuticals, Inc.
Par Pharmaceutical, Inc.
REMEDYREPACK INC.
Torrent Pharmaceuticals Limited
Sandoz Inc
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
CROSCARMELLOSE SODIUM(M28OL1HH48)   
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)   
CROSPOVIDONE(2S7830E561)     
CROSPOVIDONE(68401960MK)     
D&C YELLOW NO. 10(35SW5USQ3G)    
FD&C BLUE NO. 2(L06K8R7DQK)     
FD&C RED NO. 40(WZB9127XOA)     
FD&C YELLOW NO. 5(I753WB2F1M)     
FD&C YELLOW NO. 6(H77VEI93A8)    
FERRIC OXIDE RED(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)     
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)    
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
HYPROMELLOSES(3NXW29V3WO)    
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)     
POLYETHYLENE GLYCOL 400(B697894SGQ)   
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)     
POLYSORBATE 20(7T1F30V5YH)     
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)     
POVIDONE K30(U725QWY32X)    
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)     
STARCH, CORN(O8232NY3SJ)     
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)     
TRIETHYL CITRATE(8Z96QXD6UM)