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Setid 717fab70 632e 4a2b A6ce 82e0ced1deaf Applno 21123 Form Tablet Oral Dosage 325mg 37 5mg - Drug Product Composition: Codisal

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

USFDA APPLICATION NUMBER - 21123 / DOSAGE - TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
tramadol hydrochloride(UNII: 9N7R477WCK)
(tramadol - UNII:39J1LGJ30J)
tramadol hydrochloride37.5mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Janssen Pharmaceuticals, Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
carnauba wax(R12CBM0EIZ)
FERRIC OXIDE RED(1K09F3G675)    
FERROSOFERRIC OXIDE(XM0M87F357) 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)   
hypromelloses(3NXW29V3WO)  
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
polyethylene glycols(3WJQ0SDW1A)   
polysorbate 80(6OZP39ZG8H)
powdered cellulose(SMD1X3XO9M)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
titanium dioxide(15FIX9V2JP)