OXAPROZIN- oxaprozin tablet, film coated 
Neolpharma, Inc.

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Oxaprozin 600 mg 100 tablets, Neolpharma as CMO

Oxaprozin 600 mg Tablet

oxaprozin caplets

OXAPROZIN 
oxaprozin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55466-140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXAPROZIN (UNII: MHJ80W9LRB) (OXAPROZIN - UNII:MHJ80W9LRB) OXAPROZIN600 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code 1381;DAYPRO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55466-140-12100 in 1 BOTTLE; Type 0: Not a Combination Product10/29/1992
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA01884110/29/1992
Labeler - Neolpharma, Inc. (078709787)
Registrant - Neolpharma, Inc. (078709787)
Establishment
NameAddressID/FEIBusiness Operations
Neolpharma, Inc.078709787manufacture(55466-140) , analysis(55466-140) , pack(55466-140) , label(55466-140)

Revised: 12/2016
Document Id: 437a45eb-d829-344d-e054-00144ff88e88
Set id: 437a45eb-d828-344d-e054-00144ff88e88
Version: 1
Effective Time: 20161212
 
Neolpharma, Inc.