ZALDYON: Package Insert and Label Information

ZALDYON — mesalamine tablet, delayed release
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1353-8 in bottle of 180 tablets

ZALDYON (Mesalamine) delayed-release Tablets USP, 800 mg

Rx only

180 tablets

ZYDUS

Zaldyon(mesalamine)-DR Tab-800mg
(click image for full-size original)
ZALDYON
mesalamine tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1353
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 800 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
METHACRYLIC ACID
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
SHELLAC
Product Characteristics
Color RED (REDDISH-BROWN) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 435
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1353-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1353-2)
1 NDC:70771-1353-2 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1353-4)
2 NDC:70771-1353-8 180 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203286 01/17/2019
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1353), MANUFACTURE (70771-1353)

Revised: 10/2022 Zydus Lifesciences Limited

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