0363-1133 NDC - 12 HOUR ALLERGY AND CONGESTION (LORATADINE, PSEUDOEPHEDRINE SULFATE)

Drug Information

Product NDC: 0363-1133

Proprietary Name: 12 hour allergy and congestion

Non Proprietary Name: loratadine, Pseudoephedrine sulfate

Active Ingredient(s):
  • 5 mg/1 LORATADINE;
  • 120 mg/1 PSEUDOEPHEDRINE SULFATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE

Pharmacy Class(es):
  • Adrenergic alpha-Agonists [MoA];
  • alpha-Adrenergic Agonist [EPC]

Labeler Information

Labeler Name: Walgreen Company
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA076050
Marketing Category: ANDA
Start Marketing Date:5/5/2018

Package Information

No. Package Code Package Description Billing Unit
10363-1133-4610 BLISTER PACK in 1 CARTON (0363-1133-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
20363-1133-6020 BLISTER PACK in 1 CARTON (0363-1133-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
30363-1133-6530 BLISTER PACK in 1 CARTON (0363-1133-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-1133The 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 NAME12 hour allergy 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 NAMEloratadine, Pseudoephedrine sulfateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATED, EXTENDED 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 DATE5/5/2018This 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 NUMBERANDA076050This 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.
SUBSTANCE NAMELORATADINE; PSEUDOEPHEDRINE SULFATEAn 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 STRENGTH5; 120 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAdrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] 

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This page was last updated on: 2/1/2023