INDOMETHACIN- indomethacin suppository 
Zydus Lifesciences Limited

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INDOMETHACIN suppositories, for rectal use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1766-7

Indomethacin Suppositories USP, 50 mg

30 rectal suppositories

Rx only

carton
INDOMETHACIN 
indomethacin suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1766
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN50 mg
Inactive Ingredients
Ingredient NameStrength
HARD FAT (UNII: 8334LX7S21)  
Product Characteristics
ColorWHITE (off-white to yellowish white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1766-75 in 1 CARTON08/03/2023
1NDC:70771-1766-66 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21618408/03/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1766) , MANUFACTURE(70771-1766)

Revised: 8/2023
Document Id: 6d0a7b56-9d42-4fe8-9166-408267ded644
Set id: c6ca86fb-df23-42c1-9d29-f15312faf60c
Version: 1
Effective Time: 20230803
 
Zydus Lifesciences Limited