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Drug Product Composition: Acetaminophen

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$ API Ref.Price (USD/KG) : 7Xls

USFDA APPLICATION NUMBER - 204031 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D)
ACETAMINOPHEN325mg
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570)
OXYCODONE HYDROCHLORIDE7.5mg

Inactive Ingredients

Ingredient Name
PD-Rx Pharmaceuticals, Inc.
SpecGx LLC
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS CITRIC ACID(XF417D3PSL)
CROSCARMELLOSE SODIUM(M28OL1HH48)
EDETATE DISODIUM(7FLD91C86K)
FD&C BLUE NO. 2(L06K8R7DQK)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133) 
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 9000(V146K8QJ07)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)