cetirizine hydrochloride

Generic: cetirizine hydrochloride allergy

Labeler: leader/ cardinal health 110, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride allergy
Labeler leader/ cardinal health 110, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
LEADER/ CARDINAL HEALTH 110, INC.

Identifiers & Regulatory

Product NDC 70000-0047
Product ID 70000-0047_5c5725c9-4879-424d-829c-44017284977a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2020-03-26

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 700000047
Hyphenated Format 70000-0047

Supplemental Identifiers

RxCUI
1014678
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 allergy (source: ndc)
Application Number ANDA090760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 365 TABLET in 1 BOTTLE (70000-0047-1)
source: ndc

Packages (1)

70000-0047-1 365 TABLET in 1 BOTTLE (70000-0047-1)

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": "5c5725c9-4879-424d-829c-44017284977a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["0cab7aa8-ded3-46f1-b801-2663cc9b0173"], "manufacturer_name": ["LEADER/ CARDINAL HEALTH 110, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 BOTTLE (70000-0047-1)", "package_ndc": "70000-0047-1", "marketing_start_date": "20200326"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "70000-0047_5c5725c9-4879-424d-829c-44017284977a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0047", "generic_name": "Cetirizine Hydrochloride Allergy", "labeler_name": "LEADER/ CARDINAL HEALTH 110, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20200326", "listing_expiration_date": "20261231"}