50580-726 NDC - ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)

Drug Information

  • Product NDC: 50580-726
  • Proprietary Name: Zyrtec Allergy
  • Non Proprietary Name: Cetirizine Hydrochloride
  • Active Ingredient(s): 10 mg/1 CETIRIZINE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Kenvue Brands LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA019835
Marketing Category: NDA
Start Marketing Date:1/1/2008

Package Information

No. Package Code Package Description Billing Unit
150580-726-0350 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK
250580-726-0550 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH
350580-726-133 BLISTER PACK in 1 CARTON (50580-726-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK
450580-726-252500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH
550580-726-305 BLISTER PACK in 1 PACKAGE (50580-726-30) / 1 TABLET, FILM COATED in 1 BLISTER PACKEA
650580-726-3214 BLISTER PACK in 1 PACKAGE (50580-726-32) / 1 TABLET, FILM COATED in 1 BLISTER PACKEA
750580-726-361 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
850580-726-381 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-38) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
950580-726-401 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1050580-726-451 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE
1150580-726-501 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1250580-726-512 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-51) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1350580-726-6675 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)
1450580-726-701 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1550580-726-711 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE
1650580-726-721 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE
1750580-726-731 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE
1850580-726-741 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE
1950580-726-751 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE
2050580-726-902 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2150580-726-912500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH
2250580-726-9250 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH
2350580-726-933 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCHEA
2450580-726-941 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE
2550580-726-951 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE
2650580-726-965 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCHEA
2750580-726-9714 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC50580-726The 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 NAMEZyrtec AllergyThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECetirizine HydrochlorideThe 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 COATEDThe 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 DATE1/1/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA019835This 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 NAMEKenvue Brands LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECETIRIZINE 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 STRENGTH10 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] 

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 12/6/2025

Previous Code
Next Code