LINEZOLID - linezolid tablet, film coated 
Zydus Lifesciences Limited

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LINEZOLID TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1111-1

Linezolid Tablets, 600 mg

Rx only

100 tablets

Linezolid Tablets, 600mg
LINEZOLID 
linezolid tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J) LINEZOLID600 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code 413
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1111-220 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
2NDC:70771-1111-330 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
3NDC:70771-1111-990 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
4NDC:70771-1111-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
5NDC:70771-1111-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
6NDC:70771-1111-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20609708/09/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1111) , MANUFACTURE(70771-1111)

Revised: 10/2022
Document Id: 4997a8cd-463d-4c0d-8b97-710ceb8b3cf5
Set id: ddb0fa30-f646-4216-a455-b5dd1971816f
Version: 5
Effective Time: 20221013
 
Zydus Lifesciences Limited