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Drug Product Composition: Acetavance

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

USFDA APPLICATION NUMBER - 87003 / DOSAGE - TABLET;ORAL - 325MG;5MG

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 HYDROCHLORIDE5mg

Inactive Ingredients

Ingredient Name
PD-Rx Pharmaceuticals, Inc.
PharmPak, Inc.
A-S Medication Solutions
Actavis Pharma, Inc.
Allergan, Inc.
American Health Packaging
Aphena Pharma Solutions - Tennessee, Inc.
Aphena Pharma Solutions - Tennessee, LLC
Avera McKennan Hospital
AvKARE, Inc.
Bryant Ranch Prepack
Cardinal Health
DIRECT RX
Elite Laboratories, Inc.
Lake Erie Medical DBA Quality Care Products LLC
Larken Laboratories Inc.
Major Pharmaceuticals
Mayne Pharma
Mayne Pharma Inc.
McKesson Contract Packaging
Mylan Pharmaceuticals Inc.
Par Pharmaceutical
Par Pharmaceutical, Inc.
REMEDYREPACK INC.
RxPak Division of McKesson Corp.
St. Mary's Medical Park Pharmacy
STAT RX USA LLC
McKesson Corporation dba SKY Packaging
McKesson Packaging Services a business unit of McKesson Corproration
Mckesson Rxpak Inc
Mylan Institutional Inc.
Preferred Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
Sun Pharmaceutical Industries, Inc.
UCB, Inc.
West-Ward Pharmaceuticals Corp.
McKesson Corporation
Xiromed, LLC
A-S Medication Solutions LLC
Alvogen, Inc.
Medsource Pharmaceuticals
Precision Dose, Inc.
West-Ward Ph
ALUMINUM OXIDE(LMI26O6933)                                          
ANHYDROUS LACTOSE(3SY5LH9PMK)                                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                
CROSCARMELLOSE SODIUM(M28OL1HH48)           
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                               
CROSPOVIDONE(2S7830E561)                                  
CROSPOVIDONE(68401960MK)                         
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                 
D&C RED NO. 27(2LRS185U6K)                                          
D&C YELLOW NO. 10(35SW5USQ3G)                              
FD&C BLUE NO. 1(H3R47K3TBD)                                      
FD&C RED NO. 40(WZB9127XOA)                            
FD&C YELLOW NO. 5(I753WB2F1M)                                          
FD&C YELLOW NO. 6(H77VEI93A8)                         
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                        
MAGNESIUM STEARATE(70097M6I30)          
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                          
POVIDONE K30(U725QWY32X)                                     
POVIDONE(FZ989GH94E)                              
POVIDONE, UNSPECIFIED(FZ989GH94E)                        
POVIDONES(FZ989GH94E)                              
SILICON DIOXIDE(ETJ7Z6XBU4)              
SODIUM LAURYL SULFATE(368GB5141J)                             
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                                      
STARCH, CORN(O8232NY3SJ)       
Starch, Pregelatinized Corn(O8232NY3SJ)                                         
STEARIC ACID(4ELV7Z65AP)    
SUCROSE(C151H8M554)                           
TALC(7SEV7J4R1U)                                          
WATER(059QF0KO0R)