leader all day allergy (70000-0380)

Drug Facts

Product Profile

Brand Name leader all day allergy

Generic Name cetirizine hydrochloride

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0380

Product ID 70000-0380_f547a78c-52a9-40c8-b48c-7e76681b9c5d

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078336

Listing Expiration 2026-12-31

Marketing Start 2018-08-13

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 700000380

Hyphenated Format 70000-0380

Supplemental Identifiers

RxCUI

1014678

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 leader all day allergy (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA078336 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

14 BLISTER PACK in 1 CARTON (70000-0380-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (70000-0380-2) / 30 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (70000-0380-4) / 90 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (3)

70000-0380-1 14 BLISTER PACK in 1 CARTON (70000-0380-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK 70000-0380-2 1 BOTTLE in 1 CARTON (70000-0380-2) / 30 TABLET, FILM COATED in 1 BOTTLE 70000-0380-4 1 BOTTLE in 1 CARTON (70000-0380-4) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

leader all day allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "f547a78c-52a9-40c8-b48c-7e76681b9c5d", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 BLISTER PACK in 1 CARTON (70000-0380-1)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70000-0380-1", "marketing_start_date": "20180823"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0380-2)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0380-2", "marketing_start_date": "20180813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0380-4)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0380-4", "marketing_start_date": "20180813"}], "brand_name": "leader all day allergy", "product_id": "70000-0380_f547a78c-52a9-40c8-b48c-7e76681b9c5d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0380", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader all day allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20180813", "listing_expiration_date": "20261231"}