leader allergy relief d (70000-0042)

Drug Facts

Product Profile

Brand Name leader allergy relief d

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0042

Product ID 70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210719

Listing Expiration 2026-12-31

Marketing Start 2020-03-09

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 700000042

Hyphenated Format 70000-0042

Supplemental Identifiers

RxCUI

1014571

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 leader allergy relief d (source: ndc)

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA210719 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
120 mg/1

source: ndc

Packaging

24 BLISTER PACK in 1 CARTON (70000-0042-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

70000-0042-1 24 BLISTER PACK in 1 CARTON (70000-0042-1) / 1 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)

Leader Allergy Relief D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "57e2382c-9767-4be7-8d6b-db00e13b8276", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["3152060c-f613-49db-91d4-356d2070c466"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (70000-0042-1)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0042-1", "marketing_start_date": "20200309"}], "brand_name": "Leader Allergy Relief D", "product_id": "70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276", "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": "70000-0042", "generic_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Allergy Relief D", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA210719", "marketing_category": "ANDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}