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Setid 5adedc01 Ebf0 11e3 Ac10 0800200c9a66 Applno 205831 Form Capsule Extended Release Oral Dosage 50mg - Drug Product Composition: Ritalin

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$ API Ref.Price (USD/KG) : 629Xls

USFDA APPLICATION NUMBER - 205831 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49)
METHYLPHENIDATE HYDROCHLORIDE10mg | 15mg | 20mg | 30mg | 40mg | 50mg | 60mg

Inactive Ingredients

Ingredient Name
Rhodes Pharmaceuticals L.P.
CorePharma, LLC
Kremers Urban Pharmaceuticals Inc.
Mckesson Rxpak Inc
Unither Manufacturing, LLC
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)    
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)   
FERRIC OXIDE RED(1K09F3G675) 
ferric oxide yellow(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)    
GELATIN, UNSPECIFIED(2G86QN327L)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) 
HYPROMELLOSES(3NXW29V3WO)    
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POVIDONE(FZ989GH94E)    
povidone, unspecified(FZ989GH94E)  
SILICON DIOXIDE(ETJ7Z6XBU4)    
SODIUM LAURYL SULFATE(368GB5141J)    
STARCH, CORN(O8232NY3SJ)    
SUCROSE(C151H8M554)    
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIETHYL CITRATE(8Z96QXD6UM)    
WATER(059QF0KO0R)