childrens cetirizine hydrochloride (58602-856)

Drug Facts

Product Profile

Brand Name childrens cetirizine hydrochloride

Generic Name cetirizine hydrochloride

Labeler aurohealth llc

Dosage Form TABLET, ORALLY DISINTEGRATING

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-856

Product ID 58602-856_bc89802b-be9c-489d-b006-7dd0bb7e2ceb

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213557

Listing Expiration 2026-12-31

Marketing Start 2020-09-11

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 58602856

Hyphenated Format 58602-856

Supplemental Identifiers

RxCUI

1011482

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 childrens cetirizine hydrochloride (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA213557 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

11 BLISTER PACK in 1 CARTON (58602-856-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (58602-856-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
4 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

source: ndc

Packages (3)

58602-856-14 11 BLISTER PACK in 1 CARTON (58602-856-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 58602-856-75 2 BLISTER PACK in 1 CARTON (58602-856-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 58602-856-76 4 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Childrens Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "bc89802b-be9c-489d-b006-7dd0bb7e2ceb", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1011482"], "spl_set_id": ["cd895177-3c25-4a1b-81a0-b85f4877787a"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "11 BLISTER PACK in 1 CARTON (58602-856-14)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "58602-856-14", "marketing_start_date": "20200911"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-856-75)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "58602-856-75", "marketing_start_date": "20200911"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-856-76)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "58602-856-76", "marketing_start_date": "20200911"}], "brand_name": "Childrens Cetirizine Hydrochloride", "product_id": "58602-856_bc89802b-be9c-489d-b006-7dd0bb7e2ceb", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-856", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA213557", "marketing_category": "ANDA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}