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Drug Product Composition: Misoprostol

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$ API Ref.Price (USD/KG) : 466Xls

USFDA APPLICATION NUMBER - 20607 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1)
DICLOFENAC SODIUM50mg
MISOPROSTOL(UNII: 0E43V0BB57)
(MISOPROSTOL - UNII:0E43V0BB57)
MISOPROSTOL200ug

Inactive Ingredients

Ingredient Name
Putney, Inc.
A-S Medication Solutions
Actavis Pharma, Inc.
American Health Packaging
BluePoint Laboratories
Dash Pharmaceuticals LLC
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Preferred Pharmaceuticals, Inc.
Bryant Ranch Prepack
PD-Rx Pharmaceuticals, Inc.
ALCOHOL(3K9958V90M)         
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSPOVIDONE (120 .MU.M)(68401960MK)         
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)        
CROSPOVIDONE(2S7830E561)       
CROSPOVIDONE(68401960MK)        
GLYCINE(TE7660XO1C)         
GLYCOFUROL(YZC5LZ8BUB)         
HYDROGENATED CASTOR OIL(ZF94AP8MEY) 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
hypromelloses(3NXW29V3WO)    
lactose monohydrate(EWQ57Q8I5X)     
LACTOSE(J2B2A4N98G)       
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)        
magnesium stearate(70097M6I30) 
MEGLUMINE(6HG8UB2MUY)         
methacrylic acid - ethyl acrylate copolymer (1:1) type a(NX76LV5T8J)       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)       
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)       
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
POLOXAMER 188(LQA7B6G8JG)         
POVIDONE K30(U725QWY32X) 
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM CHLORIDE(451W47IQ8X)         
SODIUM HYDROXIDE(55X04QC32I)  
sodium starch glycolate type a potato(5856J3G2A2)         
starch, corn(O8232NY3SJ) 
TALC(7SEV7J4R1U) 
TRIETHYL CITRATE(8Z96QXD6UM) 
WATER(059QF0KO0R)