cetirizine

Generic: cetirizine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine
Generic Name cetirizine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2162
Product ID 72162-2162_70a5b42b-eb45-47a5-a270-afe1b83adb84
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

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 721622162
Hyphenated Format 72162-2162

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 300 TABLET, FILM COATED in 1 BOTTLE (72162-2162-2)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72162-2162-5)
source: ndc

Packages (2)

72162-2162-2 300 TABLET, FILM COATED in 1 BOTTLE (72162-2162-2) 72162-2162-5 500 TABLET, FILM COATED in 1 BOTTLE (72162-2162-5)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "70a5b42b-eb45-47a5-a270-afe1b83adb84", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["7e158fd6-268d-4ffc-a410-d054090d54c5"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (72162-2162-2)", "package_ndc": "72162-2162-2", "marketing_start_date": "20240202"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72162-2162-5)", "package_ndc": "72162-2162-5", "marketing_start_date": "20240202"}], "brand_name": "Cetirizine", "product_id": "72162-2162_70a5b42b-eb45-47a5-a270-afe1b83adb84", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72162-2162", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}