0363-0522 NDC - LORATADINE ()

Drug Information

  • Product NDC: 0363-0522
  • Proprietary Name: Loratadine
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Walgreen Company
Product Type:
FDA Application Number: ANDA076134
Marketing Category: ANDA
Start Marketing Date:12/5/2013

Package Information

No. Package Code Package Description Billing Unit
10363-0522-212 BLISTER PACK in 1 CARTON (0363-0522-21) / 10 TABLET in 1 BLISTER PACK
20363-0522-301 BOTTLE in 1 CARTON (0363-0522-30) / 30 TABLET in 1 BOTTLE
30363-0522-431 BOTTLE in 1 CARTON (0363-0522-43) / 45 TABLET in 1 BOTTLE
40363-0522-551 BOTTLE in 1 CARTON (0363-0522-55) / 150 TABLET in 1 BOTTLE
50363-0522-561 BLISTER PACK in 1 CARTON (0363-0522-56) / 5 TABLET in 1 BLISTER PACKEA
60363-0522-691 BLISTER PACK in 1 CARTON (0363-0522-69) / 10 TABLET in 1 BLISTER PACK
70363-0522-711 BOTTLE in 1 CARTON (0363-0522-71) / 70 TABLET in 1 BOTTLE
80363-0522-781 BOTTLE in 1 CARTON (0363-0522-78) / 300 TABLET in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-0522The 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.
PROPRIETARY NAMELoratadineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/5/2013This 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 NUMBERANDA076134This 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 NAMEWalgreen CompanyName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/9/2025

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