cetirizine hydrochloride (allergy) (58602-863)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)

Generic Name cetirizine hydrochloride

Labeler aurohealth llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-863

Product ID 58602-863_0b6e8c63-a76c-4184-a9cc-9691378c3ee5

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209107

Listing Expiration 2026-12-31

Marketing Start 2021-03-12

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 58602863

Hyphenated Format 58602-863

Supplemental Identifiers

RxCUI

1014675

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 ANDA209107 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (58602-863-12) / 40 CAPSULE in 1 BOTTLE

source: ndc

Packages (1)

58602-863-12 1 BOTTLE in 1 CARTON (58602-863-12) / 40 CAPSULE in 1 BOTTLE

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": "0b6e8c63-a76c-4184-a9cc-9691378c3ee5", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["0b6e8c63-a76c-4184-a9cc-9691378c3ee5"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-863-12)  / 40 CAPSULE in 1 BOTTLE", "package_ndc": "58602-863-12", "marketing_start_date": "20210312"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "58602-863_0b6e8c63-a76c-4184-a9cc-9691378c3ee5", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-863", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209107", "marketing_category": "ANDA", "marketing_start_date": "20210312", "listing_expiration_date": "20261231"}