zyrtec-d

Generic: cetirizine hydrochloride and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name zyrtec-d
Generic Name cetirizine hydrochloride and pseudoephedrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-719
Product ID 50580-719_375e0217-03e9-49ae-e063-6294a90a2716
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021150
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580719
Hyphenated Format 50580-719

Supplemental Identifiers

RxCUI
1014571 1014583
UPC
0300450204240
UNII
64O047KTOA 6V9V2RYJ8N

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-d (source: ndc)
Generic Name cetirizine hydrochloride and pseudoephedrine hydrochloride (source: ndc)
Application Number NDA021150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

50580-719-12 2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 50580-719-24 4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

cetirizine hydrochloride (5 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

ZYRTEC-D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "375e0217-03e9-49ae-e063-6294a90a2716", "openfda": {"upc": ["0300450204240"], "unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571", "1014583"], "spl_set_id": ["f1ecf9ba-1c03-7fb7-e053-2a95a90a875a"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-719-12)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-719-12", "marketing_start_date": "20230228"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-719-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-719-24", "marketing_start_date": "20230228"}], "brand_name": "ZYRTEC-D", "product_id": "50580-719_375e0217-03e9-49ae-e063-6294a90a2716", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50580-719", "generic_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ZYRTEC-D", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "NDA021150", "marketing_category": "NDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}