cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler advanced rx llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-731
Product ID 80513-731_35019a5a-fbea-124b-e063-6394a90a5ec4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 80513731
Hyphenated Format 80513-731

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE (80513-731-05)
  • 120 TABLET, COATED in 1 BOTTLE (80513-731-12)
source: ndc

Packages (2)

80513-731-05 500 TABLET, COATED in 1 BOTTLE (80513-731-05) 80513-731-12 120 TABLET, COATED in 1 BOTTLE (80513-731-12)

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": "35019a5a-fbea-124b-e063-6394a90a5ec4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["737492bf-96bd-4f7c-aa42-4910746f44bb"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (80513-731-05)", "package_ndc": "80513-731-05", "marketing_start_date": "20250501"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (80513-731-12)", "package_ndc": "80513-731-12", "marketing_start_date": "20250501"}], "brand_name": "Cetirizine hydrochloride", "product_id": "80513-731_35019a5a-fbea-124b-e063-6394a90a5ec4", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "80513-731", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}