0363-5528 NDC - LEVOCETIRIZINE DIHYDROCHLORIDE ()

Drug Information

  • Product NDC: 0363-5528
  • Proprietary Name: levocetirizine dihydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Walgreens Company
Product Type:
FDA Application Number: ANDA210375
Marketing Category: ANDA
Start Marketing Date:3/12/2018
End Marketing Date:9/6/2019

Package Information

No. Package Code Package Description Billing Unit
10363-5528-102 BLISTER PACK in 1 CARTON (0363-5528-10) / 5 TABLET, COATED in 1 BLISTER PACK
20363-5528-351 BOTTLE in 1 CARTON (0363-5528-35) / 35 TABLET, COATED in 1 BOTTLE
30363-5528-551 BOTTLE in 1 CARTON (0363-5528-55) / 55 TABLET, COATED in 1 BOTTLE
40363-5528-801 BOTTLE in 1 CARTON (0363-5528-80) / 80 TABLET, COATED in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-5528The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMElevocetirizine dihydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/12/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE9/6/2019This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEANDAName of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBERANDA210375An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
LABELER NAMEWalgreens CompanyName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 3/27/2026

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