11822-7388 NDC - ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)

Drug Information

  • Product NDC: 11822-7388
  • Proprietary Name: Allergy and Congestion
  • Non Proprietary Name: Fexofenadine HCl and Pseudoephedrine HCI
  • Active Ingredient(s): 60 mg/1 FEXOFENADINE HYDROCHLORIDE; 120 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, EXTENDED RELEASE
  • Pharmacy Class(es): Adrenergic alpha-Agonists [MoA]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; alpha-Adrenergic Agonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Rite Aid Corporation
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA076667
Marketing Category: ANDA
Start Marketing Date:7/19/2019

Package Information

No. Package Code Package Description Billing Unit
111822-7388-54 BLISTER PACK in 1 CARTON (11822-7388-5) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC11822-7388The 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 OTC 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 NAMEAllergy and CongestionThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEFexofenadine HCl and Pseudoephedrine HCIThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, EXTENDED RELEASEName of Company corresponding to the labeler code segment of the Product NDC.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/19/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAAn 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.
APPLICATION NUMBERANDA076667 
LABELER NAMERite Aid CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDEAn 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.
ACTIVE NUMERATOR STRENGTH60; 120 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAdrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] 

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This page was last updated on: 12/19/2025

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