EFAVIRENZ- efavirenz tablet, film coated 
Mylan Laboratories Limited

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PRINCIPAL DISPLAY PANEL

Efavirenz Tablets, USP 600 mg Bottle Labels
EFAVIRENZ 
efavirenz tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8) EFAVIRENZ600 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVAL (capsule shaped) Size21mm
FlavorImprint Code MYLAN;233
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65015-307-1430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/2016
2NDC:65015-307-993200 in 1 BAG; Type 0: Not a Combination Product02/17/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA09147102/17/2016
Labeler - Mylan Laboratories Limited (650547156)

Revised: 1/2018
Document Id: 12843615-fd58-464b-961c-c2a419f9f362
Set id: 12843615-fd58-464b-961c-c2a419f9f362
Version: 1
Effective Time: 20180109
 
Mylan Laboratories Limited