MESALAMINE - mesalamine capsule, extended release 
Cadila Healthcare Limited

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MESALAMINE Extended-Release Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mesalamine Extended-Release Capsules, 0.375 g

120 capsules

NDC 70771-1625-7

Rx only

mfg label
MESALAMINE 
mesalamine capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1625
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE0.375 g
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (opaque blue cap) , BLUE (opaque blue body) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code 452
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1625-7120 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20895408/13/2021
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1625) , MANUFACTURE(70771-1625)

Revised: 8/2021
Document Id: 9766ebb4-1686-4e37-b139-1866e73cf182
Set id: 04073681-a834-4f45-91c5-224b608b30e6
Version: 1
Effective Time: 20210813
 
Cadila Healthcare Limited