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Drug Product Composition: Butalbital

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$ API Ref.Price (USD/KG) : 1,004Xls

USFDA APPLICATION NUMBER - 86162 / DOSAGE - TABLET;ORAL - 325MG;50MG;40MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E)
ASPIRIN325mg
BUTALBITAL(UNII: KHS0AZ4JVK)
(BUTALBITAL - UNII:KHS0AZ4JVK)
BUTALBITAL50mg
CAFFEINE(UNII: 3G6A5W338E)
(CAFFEINE - UNII:3G6A5W338E)
CAFFEINE40mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Avera McKennan Hospital
AvPAK
Bryant Ranch Prepack
Cardinal Health
Golden State Medical Supply, Inc.
Hikma Pharmaceuticals USA Inc.
KAISER FOUNDATION HOSPITALS
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Mikart, LLC
Mirror Pharmaceuticals LLC
NuCare Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
West-ward Pharmaceutical Corp
Alvogen Inc.
KVK-Tech, Inc.
Major Pharmaceuticals
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
Colloidal Silicon Dioxide(ETJ7Z6XBU4)                  
CROSCARMELLOSE SODIUM(M28OL1HH48)      
CROSPOVIDONE (120 .MU.M)(68401960MK)                  
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                
CROSPOVIDONE(2S7830E561)             
CROSPOVIDONE(68401960MK)             
FD&C BLUE NO. 1(H3R47K3TBD)         
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)              
ISOSTEARIC ACID(X33R8U0062)                  
MAGNESIUM STEARATE(70097M6I30)    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)               
POVIDONE(FZ989GH94E)             
POVIDONE, UNSPECIFIED(FZ989GH94E)                  
POVIDONES(FZ989GH94E)             
SILICON DIOXIDE(ETJ7Z6XBU4)       
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)       
STARCH, CORN(O8232NY3SJ)    
STARCH, PREGELATINIZED CORN(O8232NY3SJ)                  
STEARIC ACID(4ELV7Z65AP)    
TALC(7SEV7J4R1U)