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Drug Product Composition: Zaleplon

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$ API Ref.Price (USD/KG) : 1,067Xls

USFDA APPLICATION NUMBER - 20859 / DOSAGE - CAPSULE;ORAL - 10MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METAXALONE(UNII: 1NMA9J598Y)
(METAXALONE - UNII:1NMA9J598Y)
METAXALONE800mg

Inactive Ingredients

Ingredient Name
St. Marys Medical Park Pharmacy
A-S Medication Solutions
Lake Erie Medical DBA Quality Care Products LLC
Teva Pharmaceuticals USA, Inc.
Unit Dose Services
PD-Rx Pharmaceuticals, Inc.
A-S Medication Solutions LLC
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Northstar Rx LLC
St Marys Medical Park Pharmacy
Bryant Ranch Prepack
Upsher-Smith Laboratories, Inc.
Preferred Pharmaceuticals Inc.
ALGINIC ACID(8C3Z4148WZ)            
ALUMINUM OXIDE(LMI26O6933)         
ANHYDROUS LACTOSE(3SY5LH9PMK)           
CALCIUM(SY7Q814VUP)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
D&C Yellow No. 10(35SW5USQ3G)     
FD&C BLUE NO. 1(H3R47K3TBD)  
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C GREEN NO. 3(3P3ONR6O1S)     
FD&C RED NO. 40(WZB9127XOA)   
FD&C YELLOW NO. 5(I753WB2F1M)          
FERRIC OXIDE RED(1K09F3G675)            
FERRIC OXIDE YELLOW(EX438O2MRT)            
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)      
GELATIN, UNSPECIFIED(2G86QN327L)        
LACTOSE MONOHYDRATE(EWQ57Q8I5X)    
LACTOSE(J2B2A4N98G)           
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)            
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)        
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)            
PROPYLENE GLYCOL(6DC9Q167V3)         
SHELLAC(46N107B71O)        
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM LAURYL SULFATE(368GB5141J)   
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)