cetirizine hydrochloride (hives relief) (58602-447)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (hives relief)

Generic Name cetirizine hydrochloride

Labeler aurohealth llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-447

Product ID 58602-447_5ebdf17c-288b-4fed-89c8-7d1f42a128d0

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA090760

Listing Expiration 2026-12-31

Marketing Start 2015-08-05

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 58602447

Hyphenated Format 58602-447

Supplemental Identifiers

RxCUI

1014676 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 (hives relief) (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 (58602-447-09) / 30 TABLET in 1 BOTTLE
1 BOTTLE in 1 CARTON (58602-447-17) / 45 TABLET in 1 BOTTLE
10 BLISTER PACK in 1 CARTON (58602-447-21) / 10 TABLET in 1 BLISTER PACK
1000 TABLET in 1 BOTTLE (58602-447-41)
75 TABLET in 1 PACKAGE, COMBINATION (58602-447-47)

source: ndc

Packages (5)

58602-447-09 1 BOTTLE in 1 CARTON (58602-447-09) / 30 TABLET in 1 BOTTLE 58602-447-17 1 BOTTLE in 1 CARTON (58602-447-17) / 45 TABLET in 1 BOTTLE 58602-447-21 10 BLISTER PACK in 1 CARTON (58602-447-21) / 10 TABLET in 1 BLISTER PACK 58602-447-41 1000 TABLET in 1 BOTTLE (58602-447-41) 58602-447-47 75 TABLET in 1 PACKAGE, COMBINATION (58602-447-47)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Hives Relief) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5ebdf17c-288b-4fed-89c8-7d1f42a128d0", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-447-09)  / 30 TABLET in 1 BOTTLE", "package_ndc": "58602-447-09", "marketing_start_date": "20150805"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-447-17)  / 45 TABLET in 1 BOTTLE", "package_ndc": "58602-447-17", "marketing_start_date": "20150805"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (58602-447-21)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-447-21", "marketing_start_date": "20150805"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (58602-447-41)", "package_ndc": "58602-447-41", "marketing_start_date": "20150805"}, {"sample": false, "description": "75 TABLET in 1 PACKAGE, COMBINATION (58602-447-47)", "package_ndc": "58602-447-47", "marketing_start_date": "20150805"}], "brand_name": "Cetirizine Hydrochloride (Hives Relief)", "product_id": "58602-447_5ebdf17c-288b-4fed-89c8-7d1f42a128d0", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-447", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Hives Relief)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20150805", "listing_expiration_date": "20261231"}