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Drug Product Composition: Ondansetron Hydrochloride

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$ API Ref.Price (USD/KG) : 1,297Xls

USFDA APPLICATION NUMBER - 20103 / DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS)
ONDANSETRON4mg | 8mg | 4mg in 5
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS)
ONDANSETRON4mg | 8mg

Inactive Ingredients

Ingredient Name
GlaxoSmithKline LLC
Novartis Pharmaceuticals Corporation
ANHYDROUS CITRIC ACID(XF417D3PSL) 
ASPARTAME(Z0H242BBR1)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L) 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHYLPARABEN SODIUM(CR6K9C2NHK)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PROPYLPARABEN SODIUM(625NNB0G9N)
SODIUM BENZOATE(OJ245FE5EU) 
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR) 
SORBITOL(506T60A25R) 
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
WATER(059QF0KO0R)