cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-458
Product ID 72789-458_44086625-2cfd-7204-e063-6294a90a5b52
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076047
Listing Expiration 2026-12-31
Marketing Start 2025-04-23

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 72789458
Hyphenated Format 72789-458

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 (source: ndc)
Application Number ANDA076047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-30)
  • 365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-51)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-90)
source: ndc

Packages (4)

72789-458-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-10) 72789-458-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-30) 72789-458-51 365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-51) 72789-458-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-90)

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": "44086625-2cfd-7204-e063-6294a90a5b52", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["03c0a599-072a-10ef-e063-6394a90a9698"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-10)", "package_ndc": "72789-458-10", "marketing_start_date": "20251023"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-30)", "package_ndc": "72789-458-30", "marketing_start_date": "20250529"}, {"sample": false, "description": "365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-51)", "package_ndc": "72789-458-51", "marketing_start_date": "20250423"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-90)", "package_ndc": "72789-458-90", "marketing_start_date": "20250529"}], "brand_name": "cetirizine hydrochloride", "product_id": "72789-458_44086625-2cfd-7204-e063-6294a90a5b52", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72789-458", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076047", "marketing_category": "ANDA", "marketing_start_date": "20250423", "listing_expiration_date": "20261231"}