cetirizine hydrochloride (allergy) (21130-098)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)

Generic Name cetirizine hydrochloride

Labeler better living brands, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Better Living Brands, LLC

Identifiers & Regulatory

Product NDC 21130-098

Product ID 21130-098_4471f8dd-d97b-4a3e-a238-cbf8cd606f11

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA090760

Listing Expiration 2026-12-31

Marketing Start 2023-05-19

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 21130098

Hyphenated Format 21130-098

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 cetirizine hydrochloride (allergy) (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA090760 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (21130-098-23) / 120 TABLET in 1 BOTTLE
365 TABLET in 1 BOTTLE (21130-098-39)

source: ndc

Packages (2)

21130-098-23 1 BOTTLE in 1 CARTON (21130-098-23) / 120 TABLET in 1 BOTTLE 21130-098-39 365 TABLET in 1 BOTTLE (21130-098-39)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4471f8dd-d97b-4a3e-a238-cbf8cd606f11", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["f7e16d96-4f23-cbca-e053-6394a90aef4e"], "manufacturer_name": ["Better Living Brands, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21130-098-23)  / 120 TABLET in 1 BOTTLE", "package_ndc": "21130-098-23", "marketing_start_date": "20230519"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (21130-098-39)", "package_ndc": "21130-098-39", "marketing_start_date": "20230519"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "21130-098_4471f8dd-d97b-4a3e-a238-cbf8cd606f11", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "21130-098", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Better Living Brands, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20230519", "listing_expiration_date": "20261231"}