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Drug Product Composition: Prestwick2_000881

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$ API Ref.Price (USD/KG) : 6Xls

USFDA APPLICATION NUMBER - 20381 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A)
NIACIN500mg

Inactive Ingredients

Ingredient Name
Zydus Pharmaceuticals USA Inc
A-S Medication Solutions
AbbVie Inc.
Cardinal Health
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
ALUMINUM OXIDE(LMI26O6933)     
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
HYPROMELLOSES(3NXW29V3WO)  
POLYETHYLENE GLYCOL(3WJQ0SDW1A)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POVIDONE(FZ989GH94E)     
POVIDONE, UNSPECIFIED(FZ989GH94E)   
POVIDONES(FZ989GH94E)    
STEARIC ACID(4ELV7Z65AP)
TITANIUM DIOXIDE(15FIX9V2JP)