MESALAMINE - mesalamine tablet, delayed release
Zydus Lifesciences Limited

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MESALAMINE DELAYED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1071-1

Mesalamine Delayed-release Tablets, 1.2 g

Rx only

120 tablets

Mesalamine DR Tablets, 1.2 g

MESALAMINE
mesalamine tablet, delayed release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1071
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	1.2 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	RED (BROWN)	Score	no score
Shape	OVAL (OVAL)	Size	10mm
Flavor		Imprint Code	711
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1071-2	34 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2017
2	NDC:70771-1071-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091640	06/19/2017

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1071) , MANUFACTURE(70771-1071)

Revised: 10/2022

Document Id: fbca41b2-19be-4a61-96d9-d75fb72d8474

Set id: 29c0dd58-d2cf-40fa-bc32-0eab61937331

Version: 6

Effective Time: 20221018

Zydus Lifesciences Limited