cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler medline industries, lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-652
Product ID 53329-652_efd12ec8-8f3d-c1e3-e053-2995a90a685a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077498
Listing Expiration 2026-12-31
Marketing Start 2007-12-27

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 53329652
Hyphenated Format 53329-652

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 ANDA077498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (53329-652-38)
source: ndc

Packages (1)

53329-652-38 90 TABLET in 1 BOTTLE (53329-652-38)

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": "efd12ec8-8f3d-c1e3-e053-2995a90a685a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["6823d475-84c6-4d9f-838d-925ccfb96c97"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (53329-652-38)", "package_ndc": "53329-652-38", "marketing_start_date": "20071227"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "53329-652_efd12ec8-8f3d-c1e3-e053-2995a90a685a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53329-652", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077498", "marketing_category": "ANDA", "marketing_start_date": "20071227", "listing_expiration_date": "20261231"}