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Drug Product Composition: Zolpidem

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$ API Ref.Price (USD/KG) : 490Xls

USFDA APPLICATION NUMBER - 21774 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zolpidem tartrate(UNII: WY6W63843K)
(zolpidem - UNII:7K383OQI23)
zolpidem12.5mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
A-S Medication Solutions LLC
Actavis Pharma, Inc.
American Health Packaging
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Physicians Total Care, Inc.
St Marys Medical Park Pharmacy
STAT Rx USA LLC
Avera McKennan Hospital
Golden State Medical Supply
Golden State Medical Supply, Inc.
Par Pharmaceutical, Inc.
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
sanofi-aventis U.S. LLC
St. Mary's Medical Park Pharmacy
Unit Dose Services
ANHYDROUS LACTOSE(3SY5LH9PMK)              
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
D&C YELLOW NO. 10(35SW5USQ3G)               
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)                   
FD&C BLUE NO. 1(H3R47K3TBD)                   
FD&C BLUE NO. 2(L06K8R7DQK)        
FD&C YELLOW NO. 6(H77VEI93A8)               
FERRIC OXIDE RED(1K09F3G675)           
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)                   
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                  
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                   
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T)                 
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)            
HYPROMELLOSES(3NXW29V3WO)       
LACTOSE MONOHYDRATE(EWQ57Q8I5X)      
magnesium stearate(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                   
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)              
microcrystalline cellulose(OP1R32D61U)            
POLYDEXTROSE(VH2XOU12IE)        
POLYETHYLENE GLYCOL 1000(U076Q6Q621)                   
polyethylene glycol(3WJQ0SDW1A)                 
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)         
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)             
POLYSORBATE 80(6OZP39ZG8H)                   
POLYVINYL ALCOHOL(532B59J990)                
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)              
POTASSIUM BITARTRATE(NPT6P8P3UU)         
POVIDONE(FZ989GH94E)                  
POVIDONE, UNSPECIFIED(FZ989GH94E)                 
POVIDONES(FZ989GH94E)                  
PROPYLENE GLYCOL(6DC9Q167V3)                   
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BICARBONATE(8MDF5V39QO)              
SODIUM LAURYL SULFATE(368GB5141J)              
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)                
SUCROSE(C151H8M554)             
TALC(7SEV7J4R1U)        
TARTARIC ACID(W4888I119H)              
titanium dioxide(15FIX9V2JP)
TRIACETIN(XHX3C3X673)        
TRIETHYL CITRATE(8Z96QXD6UM)