cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8204
Product ID 68788-8204_8c22d5a9-f5d8-4f30-b41b-ae2d55db2d43
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

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 687888204
Hyphenated Format 68788-8204

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 (allergy) (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
  • 100 TABLET in 1 BOTTLE (68788-8204-0)
  • 14 TABLET in 1 BOTTLE (68788-8204-1)
  • 30 TABLET in 1 BOTTLE (68788-8204-3)
  • 15 TABLET in 1 BOTTLE (68788-8204-5)
  • 60 TABLET in 1 BOTTLE (68788-8204-6)
  • 90 TABLET in 1 BOTTLE (68788-8204-9)
source: ndc

Packages (6)

68788-8204-0 100 TABLET in 1 BOTTLE (68788-8204-0) 68788-8204-1 14 TABLET in 1 BOTTLE (68788-8204-1) 68788-8204-3 30 TABLET in 1 BOTTLE (68788-8204-3) 68788-8204-5 15 TABLET in 1 BOTTLE (68788-8204-5) 68788-8204-6 60 TABLET in 1 BOTTLE (68788-8204-6) 68788-8204-9 90 TABLET in 1 BOTTLE (68788-8204-9)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8c22d5a9-f5d8-4f30-b41b-ae2d55db2d43", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["73122009-531b-4929-bf57-494a6fc65b73"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8204-0)", "package_ndc": "68788-8204-0", "marketing_start_date": "20220401"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (68788-8204-1)", "package_ndc": "68788-8204-1", "marketing_start_date": "20220401"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8204-3)", "package_ndc": "68788-8204-3", "marketing_start_date": "20220401"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68788-8204-5)", "package_ndc": "68788-8204-5", "marketing_start_date": "20220401"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8204-6)", "package_ndc": "68788-8204-6", "marketing_start_date": "20220401"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8204-9)", "package_ndc": "68788-8204-9", "marketing_start_date": "20220401"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "68788-8204_8c22d5a9-f5d8-4f30-b41b-ae2d55db2d43", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8204", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}