cetirizine hydrochloride

Generic: cetirizine hydrochloride tablets

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride tablets
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8435
Product ID 68788-8435_f859a35b-2461-42aa-bbc9-7a75ec8c2881
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078343
Listing Expiration 2026-12-31
Marketing Start 2023-04-27

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 687888435
Hyphenated Format 68788-8435

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 tablets (source: ndc)
Application Number ANDA078343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9)
source: ndc

Packages (3)

68788-8435-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3) 68788-8435-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6) 68788-8435-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9)

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": "f859a35b-2461-42aa-bbc9-7a75ec8c2881", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["14a885e5-5e75-4a18-b5bc-6aaa748712db"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3)", "package_ndc": "68788-8435-3", "marketing_start_date": "20230427"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6)", "package_ndc": "68788-8435-6", "marketing_start_date": "20230427"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9)", "package_ndc": "68788-8435-9", "marketing_start_date": "20230427"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "68788-8435_f859a35b-2461-42aa-bbc9-7a75ec8c2881", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8435", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20230427", "listing_expiration_date": "20261231"}