cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: discount drug mart, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler discount drug mart, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Discount Drug Mart, Inc

Identifiers & Regulatory

Product NDC 53943-519
Product ID 53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078343
Listing Expiration 2026-12-31
Marketing Start 2020-01-20

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 53943519
Hyphenated Format 53943-519

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 hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

53943-519-30 1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE 53943-519-45 1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE

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": "5c71a4a6-cf88-4fdc-db4f-23235af0306b", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["c7c7e496-3682-c764-88ef-d2a09823f71e"], "manufacturer_name": ["Discount Drug Mart, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53943-519-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "53943-519-30", "marketing_start_date": "20200120"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (53943-519-45)  / 45 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "53943-519-45", "marketing_start_date": "20200120"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53943-519", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Discount Drug Mart, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20200120", "listing_expiration_date": "20261231"}