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Drug Product Composition: Dexmethylphenidate Hydrochloride

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$ API Ref.Price (USD/KG) : 6,421Xls

USFDA APPLICATION NUMBER - 21802 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE(UNII: 1678OK0E08)
(DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)
DEXMETHYLPHENIDATE HYDROCHLORIDE15mg

Inactive Ingredients

Ingredient Name
Ascent Pharmaceuticals, Inc.
Camber Pharmaceuticals, Inc.
Amneal Pharmaceuticals of New York LLC
Mylan Pharmaceuticals Inc.
American Health Packaging
Adare Pharmaceuticals Inc
Northstar Rx LLC
Sun Pharmaceutical Industries, Inc.
ACETONE(1364PS73AF)      
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)       
ALCOHOL(3K9958V90M)      
AMMONIA(5138Q19F1X)     
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)     
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)  
BUTYL ALCOHOL(8PJ61P6TS3)      
Cochineal(TZ8Z31B35M)       
D&C RED NO. 28(767IP0Y5NH)     
D&C YELLOW NO. 10(35SW5USQ3G)     
DEXTROSE(IY9XDZ35W2)       
DIMETHICONE(92RU3N3Y1O)       
ETHYLCELLULOSES(7Z8S9VYZ4B)       
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK)    
FD&C RED NO. 3(PN2ZH5LOQY)      
FD&C RED NO. 40(WZB9127XOA)     
FD&C YELLOW NO. 6(H77VEI93A8)      
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)  
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN(2G86QN327L)    
GELATIN, UNSPECIFIED(2G86QN327L)    
HYDROCHLORIC ACID(QTT17582CB)      
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)      
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W)       
Hypromellose, Unspecified(3NXW29V3WO)      
HYPROMELLOSES(3NXW29V3WO)       
ISOPROPYL ALCOHOL(ND2M416302)      
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A(NX76LV5T8J)       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)      
POLYETHYLENE GLYCOL 6000(30IQX730WE)      
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)     
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)       
POTASSIUM HYDROXIDE(WZH3C48M4T)     
Povidone, Unspecified(FZ989GH94E)       
PROPYLENE GLYCOL(6DC9Q167V3)  
Shellac(46N107B71O) 
SILICON DIOXIDE(ETJ7Z6XBU4)       
SODIUM LAURYL SULFATE(368GB5141J)     
STARCH, CORN(O8232NY3SJ)   
SUCROSE(C151H8M554)   
Talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM) 
Water(059QF0KO0R)