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Drug Product Composition: Ritalin

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$ API Ref.Price (USD/KG) : 662Xls

USFDA APPLICATION NUMBER - 21121 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 18MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49)
METHYLPHENIDATE HYDROCHLORIDE27mg | 18mg | 54mg | 36mg

Inactive Ingredients

Ingredient Name
Alvogen Inc.
ANI Pharmaceuticals, Inc.
Impax Generics
Actavis Pharma, Inc.
American Health Packaging
Avera McKennan Hospital
Bryant Ranch Prepack
Camber Pharmaceuticals, Inc.
Dr.Reddys Laboratories Inc
Mylan Pharmaceuticals Inc.
Northstar Rx LLC
XLCare Pharmaceuticals, Inc.
AvKARE, Inc.
AMMONIA(5138Q19F1X)          
Anhydrous Citric Acid(XF417D3PSL)            
Butyl Alcohol(8PJ61P6TS3)          
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)   
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 400 MPA.S AT 1%)(FC40A8XAJ3)            
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)            
carnauba wax(R12CBM0EIZ)          
cellulose acetate(3J2P07GVB6)   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
CETYL ALCOHOL(936JST6JCN)           
D&C Red No. 27(2LRS185U6K)            
D&C Yellow No. 10(35SW5USQ3G)            
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)           
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)            
ETHYLCELLULOSES(7Z8S9VYZ4B)            
Fd&C Blue No. 1(H3R47K3TBD)           
FD&C BLUE NO. 2(L06K8R7DQK)           
FD&C RED NO. 40(WZB9127XOA)       
FD&C YELLOW NO. 6(H77VEI93A8)          
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)    
FERROSOFERRIC OXIDE (XM0M87F357)            
FERROSOFERRIC OXIDE(XM0M87F357) 
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)           
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)            
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)            
Hypromellose 2910 (3 Mpa.S)(0VUT3PMY82)           
Hypromellose 2910 (6 Mpa.S)(0WZ8WG20P6)            
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)        
HYPROMELLOSES(3NXW29V3WO)      
ISOPROPYL ALCOHOL(ND2M416302)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)          
lactose(J2B2A4N98G)            
lactose, unspecified form(J2B2A4N98G)           
LECITHIN, SOYBEAN(1DI56QDM62)            
MAGNESIUM STEARATE(70097M6I30)         
PHOSPHORIC ACID(E4GA8884NN)     
POLOXAMER 124(1S66E28KXA)            
Poloxamer 188(LQA7B6G8JG)           
Polyethylene Glycol 2000000(5K3991GVWI)            
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)           
Polyethylene Glycol 7000000(G3MS6M810Y)            
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)           
POLYETHYLENE OXIDE 100000(V46Y6OJ5QB)            
POLYETHYLENE OXIDE 200000(11628IH70O)          
POLYETHYLENE OXIDE 7000000(G3MS6M810Y)         
Polysorbate 80(6OZP39ZG8H)        
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)            
POVIDONE K30(U725QWY32X)           
POVIDONE(FZ989GH94E)         
POVIDONE, UNSPECIFIED(FZ989GH94E)         
povidones(FZ989GH94E)            
propylene glycol(6DC9Q167V3) 
SHELLAC(46N107B71O)          
Silicon Dioxide(ETJ7Z6XBU4)         
Sodium Chloride(451W47IQ8X)   
SODIUM LAURYL SULFATE(368GB5141J)           
SODIUM STEARYL FUMARATE(7CV7WJK4UI)            
STARCH, CORN(O8232NY3SJ)           
stearic acid(4ELV7Z65AP)    
SUCCINIC ACID(AB6MNQ6J6L)    
SUCROSE(C151H8M554)           
TALC(7SEV7J4R1U)      
TITANIUM DIOXIDE(15FIX9V2JP)
triacetin(XHX3C3X673)         
TRIETHYL CITRATE(8Z96QXD6UM)