MESALAMINE- mesalamine tablet, delayed release 
Zydus Lifesciences Limited

----------

MESALAMINE DELAYED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1071-1

Mesalamine Delayed-release Tablets, 1.2 g

Rx only

120 tablets

Mesalamine DR Tablets, 1.2 g
MESALAMINE 
mesalamine tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1071
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE1.2 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorRED (BROWN) Scoreno score
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 711
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1071-234 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2017
2NDC:70771-1071-1120 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09164006/19/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1071) , MANUFACTURE(70771-1071)

Revised: 11/2024
Document Id: 26f195e7-e73a-48e7-b3b0-49f7cbed510a
Set id: 29c0dd58-d2cf-40fa-bc32-0eab61937331
Version: 7
Effective Time: 20241130
 
Zydus Lifesciences Limited