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Drug Product Composition: Tizanidine Hydrochloride

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$ API Ref.Price (USD/KG) : 704Xls

USFDA APPLICATION NUMBER - 21447 / DOSAGE - CAPSULE;ORAL - EQ 6MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tizanidine hydrochloride(UNII: B53E3NMY5C)
(tizanidine - UNII:6AI06C00GW)
tizanidine6mg | 4mg | 2mg

Inactive Ingredients

Ingredient Name
Mylan Pharmaceuticals Inc.
Acorda Therapeutics, Inc.
SA3, LLC
Quality Care Products, LLC
Clinical Solutions Wholesale
Par Pharmaceutical, Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
AMMONIA(5138Q19F1X)      
ANHYDROUS LACTOSE(3SY5LH9PMK)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSCARMELLOSE SODIUM(M28OL1HH48)      
ETHYL ACRYLATE(71E6178C9T)      
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)      
FD&C RED NO. 3(PN2ZH5LOQY)      
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)      
FERROSOFERRIC OXIDE(XM0M87F357)    
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)      
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)     
HYPROMELLOSES(3NXW29V3WO)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)      
METHACRYLIC ACID(1CS02G8656)      
POTASSIUM HYDROXIDE(WZH3C48M4T)   
PROPYLENE GLYCOL(6DC9Q167V3)    
SHELLAC(46N107B71O)   
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM LAURYL SULFATE(368GB5141J)      
STARCH, CORN(O8232NY3SJ)      
STEARIC ACID(4ELV7Z65AP)    
SUCROSE(C151H8M554)     
TALC(7SEV7J4R1U)     
TITANIUM DIOXIDE(15FIX9V2JP)