zyrtec allergy

Generic: cetirizine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyrtec allergy
Generic Name cetirizine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-726
Product ID 50580-726_40cb0300-d3f3-4a66-e063-6394a90a41dc
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019835
Listing Expiration 2026-12-31
Marketing Start 2008-01-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580726
Hyphenated Format 50580-726

Supplemental Identifiers

RxCUI
1014678 1020026
UPC
0312547204361
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zyrtec allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA019835 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 50 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH
  • 2500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE
  • 2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 2500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH
  • 50 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH
  • 3 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 5 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCH
  • 14 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (22)

50580-726-03 50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK 50580-726-05 50 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-25 2500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-36 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-726-40 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-726-45 1 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE 50580-726-50 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-726-66 75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66) 50580-726-70 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-726-71 1 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE 50580-726-72 1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE 50580-726-73 1 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE 50580-726-74 1 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE 50580-726-75 1 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE 50580-726-90 2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-726-91 2500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-92 50 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-93 3 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-94 1 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE 50580-726-95 1 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE 50580-726-96 5 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCH 50580-726-97 14 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Zyrtec Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40cb0300-d3f3-4a66-e063-6394a90a41dc", "openfda": {"upc": ["0312547204361"], "unii": ["64O047KTOA"], "rxcui": ["1014678", "1020026"], "spl_set_id": ["b165db38-b302-4220-8627-77cb07bb078c"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (50580-726-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-726-03", "marketing_start_date": "20080101"}, {"sample": false, "description": "50 POUCH in 1 CARTON (50580-726-05)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-05", "marketing_start_date": "20230301"}, {"sample": false, "description": "2500 POUCH in 1 CASE (50580-726-25)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-25", "marketing_start_date": "20230301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-726-36", "marketing_start_date": "20080101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40)  / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-726-40", "marketing_start_date": "20140120"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-45)  / 45 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-45", "marketing_start_date": "20250731"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-726-50", "marketing_start_date": "20100126"}, {"sample": false, "description": "75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)", "package_ndc": "50580-726-66", "marketing_start_date": "20080101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70)  / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-726-70", "marketing_start_date": "20080101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-71)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-71", "marketing_start_date": "20241101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-72)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-72", "marketing_start_date": "20241101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-73)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-73", "marketing_start_date": "20241101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-74)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-74", "marketing_start_date": "20241101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-726-75)  / 75 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-75", "marketing_start_date": "20250731"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90)  / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-726-90", "marketing_start_date": "20100126"}, {"sample": false, "description": "2500 POUCH in 1 CARTON (50580-726-91)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-91", "marketing_start_date": "20180727"}, {"sample": false, "description": "50 POUCH in 1 TRAY (50580-726-92)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-92", "marketing_start_date": "20180712"}, {"sample": false, "description": "3 POUCH in 1 CARTON (50580-726-93)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-93", "marketing_start_date": "20180727"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (50580-726-94)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-94", "marketing_start_date": "20200615"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (50580-726-95)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-726-95", "marketing_start_date": "20200615"}, {"sample": false, "description": "5 POUCH in 1 CARTON (50580-726-96)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-96", "marketing_start_date": "20200530"}, {"sample": false, "description": "14 POUCH in 1 CARTON (50580-726-97)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-726-97", "marketing_start_date": "20200530"}], "brand_name": "Zyrtec Allergy", "product_id": "50580-726_40cb0300-d3f3-4a66-e063-6394a90a41dc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-726", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zyrtec Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA019835", "marketing_category": "NDA", "marketing_start_date": "20080101", "listing_expiration_date": "20261231"}