cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6538
Product ID 50090-6538_b6221e59-ed88-4d25-a948-0f90c16f8dcf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 500906538
Hyphenated Format 50090-6538

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 ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (50090-6538-1)
  • 90 TABLET, COATED in 1 BOTTLE (50090-6538-3)
source: ndc

Packages (2)

50090-6538-1 30 TABLET, COATED in 1 BOTTLE (50090-6538-1) 50090-6538-3 90 TABLET, COATED in 1 BOTTLE (50090-6538-3)

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": "b6221e59-ed88-4d25-a948-0f90c16f8dcf", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["f4da9adf-840d-4526-86a6-6666183fd107"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-6538-1)", "package_ndc": "50090-6538-1", "marketing_start_date": "20230704"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-6538-3)", "package_ndc": "50090-6538-3", "marketing_start_date": "20230705"}], "brand_name": "Cetirizine hydrochloride", "product_id": "50090-6538_b6221e59-ed88-4d25-a948-0f90c16f8dcf", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50090-6538", "generic_name": "Cetirizine hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}