62756-543 NDC - FEXOFENADINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 62756-543
  • Proprietary Name: FEXOFENADINE HYDROCHLORIDE
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Sun Pharmaceutical Industries, Inc.
Product Type:
FDA Application Number: ANDA091567
Marketing Category: ANDA
Start Marketing Date:2/6/2012
End Marketing Date:6/27/2022

Package Information

No. Package Code Package Description Billing Unit
162756-543-1530 TABLET, FILM COATED in 1 BOTTLE (62756-543-15)
262756-543-16100 TABLET, FILM COATED in 1 BOTTLE (62756-543-16)
362756-543-271 BLISTER PACK in 1 CARTON (62756-543-27) / 5 TABLET, FILM COATED in 1 BLISTER PACK
462756-543-289 BLISTER PACK in 1 CARTON (62756-543-28) / 5 TABLET, FILM COATED in 1 BLISTER PACK
562756-543-2910 BLISTER PACK in 1 CARTON (62756-543-29) / 6 TABLET, FILM COATED in 1 BLISTER PACK
662756-543-3015 BLISTER PACK in 1 CARTON (62756-543-30) / 6 TABLET, FILM COATED in 1 BLISTER PACK
762756-543-645 BLISTER PACK in 1 CARTON (62756-543-64) / 6 TABLET, FILM COATED in 1 BLISTER PACK
862756-543-662 BLISTER PACK in 1 CARTON (62756-543-66) / 5 TABLET, FILM COATED in 1 BLISTER PACK
962756-543-741 BLISTER PACK in 1 CARTON (62756-543-74) / 5 TABLET, FILM COATED in 1 BLISTER PACK
1062756-543-7610 BLISTER PACK in 1 CARTON (62756-543-76) / 6 TABLET, FILM COATED in 1 BLISTER PACK
1162756-543-779 BLISTER PACK in 1 CARTON (62756-543-77) / 5 TABLET, FILM COATED in 1 BLISTER PACK
1262756-543-7815 BLISTER PACK in 1 CARTON (62756-543-78) / 6 TABLET, FILM COATED in 1 BLISTER PACK
1362756-543-8330 TABLET, FILM COATED in 1 BOTTLE (62756-543-83)
1462756-543-88100 TABLET, FILM COATED in 1 BOTTLE (62756-543-88)
1562756-543-942 BLISTER PACK in 1 CARTON (62756-543-94) / 5 TABLET, FILM COATED in 1 BLISTER PACK
1662756-543-955 BLISTER PACK in 1 CARTON (62756-543-95) / 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC62756-543The 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 NAMEFEXOFENADINE HYDROCHLORIDEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/6/2012This 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 NUMBERANDA091567This 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 NAMESun Pharmaceutical Industries, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC62756-543The 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 NAMEFEXOFENADINE HYDROCHLORIDEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/6/2012This 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 NUMBERANDA091567This 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 NAMESun Pharmaceutical Industries, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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