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Drug Product Composition: Diltiazem Hydrochloride

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$ API Ref.Price (USD/KG) : 94Xls

USFDA APPLICATION NUMBER - 21392 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diltiazem Hydrochloride(UNII: OLH94387TE)
(Diltiazem - UNII:EE92BBP03H)
Diltiazem Hydrochloride420mg | 360mg | 300mg | 240mg | 180mg | 120mg

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
REMEDYREPACK INC.
AbbVie Inc.
Cipla USA, Inc.
CANDELILLA WAX(WL0328HX19)  
carnauba wax(R12CBM0EIZ)   
cellulose, microcrystalline(OP1R32D61U) 
croscarmellose sodium(M28OL1HH48)   
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)(P2OM2Q86BI)   
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)   
ETHYLCELLULOSES(7Z8S9VYZ4B)  
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)   
hypromelloses(3NXW29V3WO)   
ISOPROPYL ALCOHOL(ND2M416302)   
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
microcrystalline wax(XOF597Q3KY)   
NONOXYNOL-100(A906T4D368)  
polydextrose(VH2XOU12IE)   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) 
polyethylene glycols(3WJQ0SDW1A)   
polysorbate 80(6OZP39ZG8H) 
POVIDONE K30(U725QWY32X)  
POVIDONE, UNSPECIFIED(FZ989GH94E)   
POVIDONES(FZ989GH94E)   
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)  
sucrose stearate(274KW0O50M)   
SUCROSE(C151H8M554)  
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)  
TRIETHYL CITRATE(8Z96QXD6UM)