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

Labeler Information

Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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
250580-726-133 BLISTER PACK in 1 CARTON (50580-726-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK
350580-726-305 BLISTER PACK in 1 PACKAGE (50580-726-30) > 1 TABLET, FILM COATED in 1 BLISTER PACKEA
450580-726-3214 BLISTER PACK in 1 PACKAGE (50580-726-32) > 1 TABLET, FILM COATED in 1 BLISTER PACKEA
550580-726-361 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
650580-726-381 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-38) > 45 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
750580-726-401 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) > 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
850580-726-501 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
950580-726-512 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-51) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1050580-726-6675 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)
1150580-726-701 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) > 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1250580-726-902 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) > 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1350580-726-912500 POUCH in 1 CARTON (50580-726-91) > 1 TABLET, FILM COATED in 1 POUCH
1450580-726-9250 POUCH in 1 TRAY (50580-726-92) > 1 TABLET, FILM COATED in 1 POUCH
1550580-726-933 POUCH in 1 CARTON (50580-726-93) > 1 TABLET, FILM COATED in 1 POUCHEA

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 NAMEJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECETIRIZINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/1 

Download Record

Download this NDC record in Text format: Export

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

Download this NDC record in XML format: Export

This page was last updated on: 3/20/2020