MESALAMINE - mesalamine tablet, delayed release 
Zydus Lifesciences Limited

----------

MESALAMINE DELAYED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1110-8 in bottle of 180 tablets

Mesalamine Delayed-release Tablets USP, 800 mg

Rx only

180 tablets

Mesalamine Delayed-release Tablets USP, 800 mg
MESALAMINE 
mesalamine tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE800 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIA (UNII: 5138Q19F1X)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorRED (REDDISH-BROWN) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 435
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1110-8180 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
2NDC:70771-1110-410 in 1 CARTON08/02/2018
2NDC:70771-1110-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20328608/02/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1110) , MANUFACTURE(70771-1110)

Revised: 10/2022
Document Id: d2c38484-6336-42c1-9ad0-5c3a31eaf6bd
Set id: 52d96501-47f3-45d8-a181-98763b9f8965
Version: 5
Effective Time: 20221018
 
Zydus Lifesciences Limited