cetirizine hydrochloride (85293-001)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride

Generic Name cetirizine hydrochloride

Labeler umasuto, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Umasuto, LLC

Identifiers & Regulatory

Product NDC 85293-001

Product ID 85293-001_2fb2f0c8-a45a-5c2a-e063-6394a90a1587

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA077829

Listing Expiration 2026-12-31

Marketing Start 2025-03-04

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 85293001

Hyphenated Format 85293-001

Supplemental Identifiers

RxCUI

1014678

UPC

0385293001010

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 (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA077829 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (85293-001-01)

source: ndc

Packages (1)

85293-001-01 100 TABLET in 1 BOTTLE (85293-001-01)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2fb2f0c8-a45a-5c2a-e063-6394a90a1587", "openfda": {"upc": ["0385293001010"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["9af4ab23-d6d3-43f9-a026-76fd9771963f"], "manufacturer_name": ["Umasuto, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (85293-001-01)", "package_ndc": "85293-001-01", "marketing_start_date": "20250304"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "85293-001_2fb2f0c8-a45a-5c2a-e063-6394a90a1587", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "85293-001", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Umasuto, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077829", "marketing_category": "ANDA", "marketing_start_date": "20250304", "listing_expiration_date": "20261231"}