cetirizine hydrochloride

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-465
Product ID 69452-465_45745bf3-a132-b51a-e063-6394a90a712e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078862
Listing Expiration 2026-12-31
Marketing Start 2024-10-20

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 69452465
Hyphenated Format 69452-465

Supplemental Identifiers

RxCUI
1014678
UPC
0369458265233
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 ANDA078862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81)
source: ndc

Packages (1)

69452-465-81 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81)

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": "45745bf3-a132-b51a-e063-6394a90a712e", "openfda": {"upc": ["0369458265233"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["831d4141-b3be-4d98-a372-9c4d57ad296c"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81)", "package_ndc": "69452-465-81", "marketing_start_date": "20241020"}], "brand_name": "CETIRIZINE HYDROCHLORIDE", "product_id": "69452-465_45745bf3-a132-b51a-e063-6394a90a712e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69452-465", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CETIRIZINE HYDROCHLORIDE", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078862", "marketing_category": "ANDA", "marketing_start_date": "20241020", "listing_expiration_date": "20261231"}