MESALAMINE - mesalamine suppository 
Zydus Lifesciences Limited

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MESALAMINE SUPPOSITORIES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1513-6

Mesalamine suppositories, 1000 mg

30 rectal suppositories

Rx only

Blister label

Image

NDC 70771-1513-7

Mesalamine rectal suppositories, 1000 mg

30 rectal suppositories

Rx only

Carton label

Image

MESALAMINE 
mesalamine suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1513
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE1000 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD (UNII: 8334LX7S21)  
Product Characteristics
ColorWHITE (OFF WHITE TO LIGHT TAN COLORED) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1513-75 in 1 POUCH02/14/2020
1NDC:70771-1513-66 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20895302/14/2020
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (650650802)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1513) , MANUFACTURE(70771-1513)

Revised: 10/2022
Document Id: 2d9461f3-adf4-4c79-9cec-f4c224b24928
Set id: aa63b4bb-2de7-40aa-b26b-1b00b0183eac
Version: 3
Effective Time: 20221031
 
Zydus Lifesciences Limited