MESALAMINE capsule, extended release

Mesalamine by

Drug Labeling and Warnings

Mesalamine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mesalamine Extended-Release Capsules, 0.375 g

120 capsules

NDC: 70771-1625-7

Rx only

INGREDIENTS AND APPEARANCE

MESALAMINE 
mesalamine capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1625
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	0.375 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE (opaque blue cap) , BLUE (opaque blue body)	Score	no score
Shape	CAPSULE	Size	24mm
Flavor		Imprint Code	452
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1625-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208954	08/13/2021

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1625) , MANUFACTURE(70771-1625)