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Drug Product Composition: Celecoxib

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$ API Ref.Price (USD/KG) : 50Xls

USFDA APPLICATION NUMBER - 20998 / DOSAGE - CAPSULE;ORAL - 200MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB(UNII: JCX84Q7J1L)
(CELECOXIB - UNII:JCX84Q7J1L)
CELECOXIB100mg | 200mg

Inactive Ingredients

Ingredient Name
Cardinal Health 107, LLC
Major Pharmaceuticals
Modavar Pharmaceuticals LLC
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc
Preferred Pharmaceuticals Inc.
RedPharm Drug, Inc.
REMEDYREPACK INC.
St. Mary's Medical Park Pharmacy
UMEDICA LABORATORIES PRIVATE LIMITED
A-S Medication Solutions
Bryant Ranch Prepack
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Lake Erie Medical DBA Quality Care Products LLC
A-S Medication Solutions LLC
Actavis Pharma, Inc.
Avera McKennan Hospital
Cardinal Health
Chartwell RX, LLC
Cipla USA Inc.
Clinical Solutions Wholesale
EMC PHARMA, LLC
Exelan Pharmaceuticals, Inc
Golden State Medical Supply, Inc.
Greenstone LLC
Lupin Pharmaceuticals, Inc.
medsource pharmaceuticals
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
NorthStar RxLLC
Northwind Pharmaceuticals, LLC
PD-Rx Pharmaceuticals, Inc.
PFIZER LABORATORIES DIV PFIZER INC
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
Quallent Pharmaceuticals Health LLC
Torrent Pharmaceuticals Limited
Trigen Laboratories, LLC
Unit Dose Services
Viatris Specialty LLC
Yiling Pharmaceutical, Inc.
Amneal Pharmaceuticals LLC
AvKARE, Inc.
Yiling Pharmace
REMEDYREPACK IN
Medsource Pharmaceuticals
R
ALCOHOL(3K9958V90M)                                      
AMMONIA(5138Q19F1X)                                  
BUTYL ALCOHOL(8PJ61P6TS3)                                      
CROSCARMELLOSE SODIUM(M28OL1HH48)             
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)                                                
CROSPOVIDONE (120 .MU.M)(68401960MK)                                             
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                             
CROSPOVIDONE(2S7830E561)                                               
CROSPOVIDONE(68401960MK)                                          
D&C RED NO. 28(767IP0Y5NH)                                             
D&C RED NO. 33(9DBA0SBB0L)                                              
D&C YELLOW NO. 10(35SW5USQ3G)                                         
DIMETHICONE(92RU3N3Y1O)                                         
FD&C BLUE NO. 1(H3R47K3TBD)                                     
FD&C BLUE NO. 2(L06K8R7DQK)                                  
FD&C GREEN NO. 3(3P3ONR6O1S)                                              
FD&C RED NO. 3(PN2ZH5LOQY)                                         
FD&C RED NO. 40(WZB9127XOA)                                        
FD&C YELLOW NO. 5(I753WB2F1M)                                                
FD&C YELLOW NO. 6(H77VEI93A8)                                             
FERRIC OXIDE RED(1K09F3G675)                                            
FERRIC OXIDE YELLOW(EX438O2MRT)                                
FERROSOFERRIC OXIDE(XM0M87F357)                           
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)(0K9R94573C)                                                
GELATIN(2G86QN327L)                  
GELATIN, UNSPECIFIED(2G86QN327L)                             
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                                
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                                
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                                
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                               
ISOPROPYL ALCOHOL(ND2M416302)                                      
LACTOSE MONOHYDRATE(EWQ57Q8I5X)            
MAGNESIUM STEARATE (70097M6I30)                                                
MAGNESIUM STEARATE(70097M6I30)            
MANNITOL(3OWL53L36A)                                              
POTASSIUM HYDROXIDE(WZH3C48M4T)                                
POVIDONE K12(333AG72FWJ)                                               
POVIDONE K30(U725QWY32X)                                  
POVIDONE(FZ989GH94E)                              
POVIDONE, UNSPECIFIED(FZ989GH94E)                              
POVIDONES(FZ989GH94E)                                          
PROPYLENE GLYCOL(6DC9Q167V3)                 
SHELLAC(46N107B71O)                  
SHELLAC(MB5IUD6JUA)                                             
SILICON DIOXIDE(ETJ7Z6XBU4)                                             
SODIUM HYDROXIDE(55X04QC32I)                                              
SODIUM LAURYL SULFATE(368GB5141J)           
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                                           
TALC(7SEV7J4R1U)                                                
TITANIUM DIOXIDE(15FIX9V2JP)                 
WATER(059QF0KO0R)