zyrtec allergy

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name zyrtec allergy
Generic Name cetirizine hydrochloride
Labeler kenvue brands llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-786
Product ID 50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213105
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 50580786
Hyphenated Format 50580-786

Supplemental Identifiers

RxCUI
1014675 1020023
UPC
0300450204318
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 ANDA213105 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)
  • 65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)
source: ndc

Packages (8)

50580-786-12 1 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-13 1 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-25 1 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-26 1 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-40 1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-41 1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 50580-786-65 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65) 50580-786-66 65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)

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": "41a5a9a1-61a6-f771-e063-6294a90aed87", "openfda": {"upc": ["0300450204318"], "unii": ["64O047KTOA"], "rxcui": ["1014675", "1020023"], "spl_set_id": ["0face45c-af24-3559-e063-6294a90abde5"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (50580-786-12)  / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-12", "marketing_start_date": "20240415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-786-13)  / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-13", "marketing_start_date": "20241201"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (50580-786-25)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-25", "marketing_start_date": "20240415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-786-26)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-26", "marketing_start_date": "20241201"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (50580-786-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-40", "marketing_start_date": "20240415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-786-41)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "50580-786-41", "marketing_start_date": "20241201"}, {"sample": false, "description": "65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)", "package_ndc": "50580-786-65", "marketing_start_date": "20240415"}, {"sample": false, "description": "65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)", "package_ndc": "50580-786-66", "marketing_start_date": "20241201"}], "brand_name": "ZYRTEC Allergy", "product_id": "50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-786", "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": "ANDA213105", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}