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Drug Product Composition: Naproxen Sodium

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$ API Ref.Price (USD/KG) : 37Xls

USFDA APPLICATION NUMBER - 18164 / DOSAGE - TABLET;ORAL - EQ 500MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naproxen sodium(UNII: 9TN87S3A3C)
(naproxen - UNII:57Y76R9ATQ)
naproxen sodium550mg
naproxen(UNII: 57Y76R9ATQ)
(naproxen - UNII:57Y76R9ATQ)
naproxen500mg | 375mg | 500mg

Inactive Ingredients

Ingredient Name
bryant ranch prepack
Dr. Reddy's Laboratories Inc.
Hikma Pharmaceutical
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
Quality Care Products, LLC
REMEDYREPACK INC.
Teva Pharmaceuticals USA Inc
West-Ward Pharmaceuticals Corp
A-S Medication Solutions
Amneal Pharmaceuticals LLC
AvKARE, Inc.
Bryant Ranch Prepack
Genentech, Inc.
Major Pharmaceuticals
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
Unit Dose Services
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)          
CROSCARMELLOSE SODIUM(M28OL1HH48)      
FD&C BLUE NO. 2(L06K8R7DQK)         
FERRIC OXIDE RED(1K09F3G675)               
FERRIC OXIDE YELLOW(EX438O2MRT)                   
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)               
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                   
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                
HYPROMELLOSES(3NXW29V3WO)                
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                  
MAGNESIUM STEARATE(70097M6I30)  
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)                    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)               
POLYETHYLENE GLYCOL 400(B697894SGQ)             
POLYETHYLENE GLYCOL 6000(30IQX730WE)                    
polyethylene glycol 8000(Q662QK8M3B)              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                 
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                   
POLYVINYL ALCOHOL(532B59J990)               
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                 
POVIDONE K30(U725QWY32X)               
povidone K90(RDH86HJV5Z)                    
POVIDONE(FZ989GH94E)            
POVIDONE, UNSPECIFIED(FZ989GH94E)             
POVIDONES(FZ989GH94E)                
SILICON DIOXIDE(ETJ7Z6XBU4)           
sodium hydroxide(55X04QC32I)                    
SODIUM LAURYL SULFATE(368GB5141J)                  
TALC(7SEV7J4R1U)   
TITANIUM DIOXIDE(15FIX9V2JP)    
triethyl citrate(8Z96QXD6UM)                    
water(059QF0KO0R)