Package 50580-128-04

Brand: zyrtec hives

Generic: cetirizine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 50580-128-04
Digits Only 5058012804
Product NDC 50580-128
Description

1 BOTTLE in 1 CARTON (50580-128-04) / 118 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2025-04-02
Brand zyrtec hives
Generic cetirizine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "37b3c47a-f31a-20f4-e063-6294a90ab07a", "openfda": {"upc": ["0300450139146"], "unii": ["64O047KTOA"], "rxcui": ["1014673", "1020021"], "spl_set_id": ["31400cb2-fe85-ef74-e063-6294a90a11fb"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-128-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-128-04", "marketing_start_date": "20250402"}], "brand_name": "ZYRTEC HIVES", "product_id": "50580-128_37b3c47a-f31a-20f4-e063-6294a90ab07a", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-128", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ZYRTEC HIVES", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA022155", "marketing_category": "NDA", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}