70771-1353 NDC - ZALDYON (MESALAMINE)

Drug Information

Product NDC: 70771-1353

Proprietary Name: ZALDYON

Non Proprietary Name: mesalamine

Active Ingredient(s):
  • 800 mg/1 MESALAMINE


Administration Route(s): ORAL

Dosage Form(s): TABLET, DELAYED RELEASE

Pharmacy Class(es):
  • Aminosalicylate [EPC];
  • Aminosalicylic Acids [CS]

Labeler Information

Labeler Name: Cadila Healthcare Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA203286
Marketing Category: ANDA
Start Marketing Date:1/17/2019

Package Information

No. Package Code Package Description Billing Unit
170771-1353-410 BLISTER PACK in 1 CARTON (70771-1353-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1353-2)
270771-1353-8180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1353-8)

NDC Record

Field Name Field Value Definition
PRODUCT NDC70771-1353The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEZALDYONThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEmesalamineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, DELAYED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/17/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA203286This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECadila Healthcare LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMESALAMINEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH800 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAminosalicylate [EPC],Aminosalicylic Acids [CS] 

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This page was last updated on: 11/18/2019