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Drug Product Composition: Altiazem

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$ API Ref.Price (USD/KG) : 93Xls

USFDA APPLICATION NUMBER - 20401 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H)
DILTIAZEM HYDROCHLORIDE180mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Bryant Ranch Prepack
Cardinal Health
NuCare Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
REMEDYREPACK INC.
St Marys Medical Park Pharmacy
American Health Packaging
Apotex Corp.
Avera McKennan Hospital
Bausch Health US LLC
Actavis Elizabeth LLC
Sandoz Inc
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)      
ALUMINUM OXIDE(LMI26O6933)            
AMMONIA(5138Q19F1X)            
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)          
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)      
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)            
castor oil(D5340Y2I9G)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
D&C RED NO. 28(767IP0Y5NH)         
D&C YELLOW NO. 10(35SW5USQ3G)          
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI)       
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)            
ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY)       
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)            
ETHYLCELLULOSES(7Z8S9VYZ4B)           
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)           
FD&C GREEN NO. 3(3P3ONR6O1S)        
FD&C RED NO. 3(PN2ZH5LOQY)          
FD&C Red No. 40(WZB9127XOA)       
FERROSOFERRIC OXIDE(XM0M87F357)
fumaric acid(88XHZ13131)            
GELATIN(2G86QN327L)   
GELATIN, UNSPECIFIED(2G86QN327L)        
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)            
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)           
HYDROXYPROPYL CELLULOSE(RFW2ET671P)            
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)            
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
HYPROMELLOSES(3NXW29V3WO)         
MAGNESIUM STEARATE(70097M6I30)    
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)          
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)          
METHYLCELLULOSE (15 CPS)(NPU9M2E6L8)            
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)           
NONOXYNOL-100(A906T4D368)            
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)            
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)          
POLYSORBATE 80(6OZP39ZG8H)    
POTASSIUM HYDROXIDE(WZH3C48M4T)        
POVIDONE K30(U725QWY32X)            
POVIDONE, UNSPECIFIED(FZ989GH94E)            
POVIDONES(FZ989GH94E)         
PROPYLENE GLYCOL(6DC9Q167V3)       
SHELLAC(46N107B71O)       
SILICON DIOXIDE(ETJ7Z6XBU4)      
SODIUM LAURYL SULFATE(368GB5141J)    
STARCH, CORN(O8232NY3SJ)        
stearic acid(4ELV7Z65AP)            
SUCROSE STEARATE(274KW0O50M)         
sucrose(C151H8M554)      
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)    
white wax(7G1J5DA97F)