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Drug Product Composition: Methylphenidate Hydrochloride

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$ API Ref.Price (USD/KG) : 690Xls

USFDA APPLICATION NUMBER - 21259 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylphenidate hydrochloride(UNII: 4B3SC438HI)
(methylphenidate - UNII:207ZZ9QZ49)
methylphenidate hydrochloride60mg | 50mg | 40mg | 30mg | 20mg | 10mg

Inactive Ingredients

Ingredient Name
Mayne Pharma
Granules Pharmaceuticals Inc.
American Health Packaging
Rhodes Pharmaceuticals L.P.
CorePharma, LLC
Kremers Urban Pharmaceuticals Inc.
Mckesson Rxpak Inc
Unither Manufacturing, LLC
ACETONE(1364PS73AF)       
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)      
ALUMINUM OXIDE(LMI26O6933)       
AMMONIA(5138Q19F1X)      
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)       
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(BEI30UXK2N)       
CELLULOSE ACETATE(3J2P07GVB6)       
CETYL ALCOHOL(936JST6JCN)      
D&C RED NO. 28(767IP0Y5NH)     
D&C RED NO. 33(9DBA0SBB0L)       
D&C YELLOW NO. 10(35SW5USQ3G)    
dibutyl sebacate(4W5IH7FLNY)   
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)    
FD&C YELLOW NO. 5(I753WB2F1M)       
FD&C YELLOW NO. 6(H77VEI93A8)      
FERRIC OXIDE RED(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)  
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)      
GELATIN, UNSPECIFIED(2G86QN327L)   
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W)       
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(36BGF0E889)       
hypromellose, unspecified(3NXW29V3WO)  
HYPROMELLOSES(3NXW29V3WO)       
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)       
POLYETHYLENE GLYCOL(3WJQ0SDW1A)       
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POTASSIUM HYDROXIDE(WZH3C48M4T)       
POVIDONE(FZ989GH94E)       
povidone, unspecified(FZ989GH94E)     
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)     
SHELLAC(MB5IUD6JUA)       
SILICON DIOXIDE(ETJ7Z6XBU4)       
SODIUM LAURYL SULFATE(368GB5141J)      
STARCH, CORN(O8232NY3SJ)    
SUCROSE(C151H8M554)    
TALC(7SEV7J4R1U)     
titanium dioxide(15FIX9V2JP) 
TRIETHYL CITRATE(8Z96QXD6UM)       
WATER(059QF0KO0R)