cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5399
Product ID 55154-5399_897f5838-b1e4-472f-9348-f001dd1d5f22
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076677
Listing Expiration 2026-12-31
Marketing Start 2012-03-30

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 551545399
Hyphenated Format 55154-5399

Supplemental Identifiers

RxCUI
1014678
UPC
0055154539906
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 (source: ndc)
Application Number ANDA076677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-5399-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-5399-0 10 BLISTER PACK in 1 BAG (55154-5399-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "897f5838-b1e4-472f-9348-f001dd1d5f22", "openfda": {"upc": ["0055154539906"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["0b0190c7-acfd-4140-bcaf-9fe835ebaf49"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-5399-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-5399-0", "marketing_start_date": "20120330"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "55154-5399_897f5838-b1e4-472f-9348-f001dd1d5f22", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55154-5399", "generic_name": "cetirizine hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076677", "marketing_category": "ANDA", "marketing_start_date": "20120330", "listing_expiration_date": "20261231"}