cetirizine hydrochloride oral solution (83745-185)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride oral solution

Generic Name cetirizine hydrochloride oral solution

Labeler apozeal pharmaceuticals inc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer

APOZEAL PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 83745-185

Product ID 83745-185_b350aaa9-197e-4ebc-8315-6ea307dcdb2e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078870

Listing Expiration 2027-12-31

Marketing Start 2024-12-20

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 83745185

Hyphenated Format 83745-185

Supplemental Identifiers

RxCUI

1014673

UPC

0383745185042 0383745185165 0383745185080

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 oral solution (source: ndc)

Generic Name cetirizine hydrochloride oral solution (source: ndc)

Application Number ANDA078870 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1 mg/mL

source: ndc

Packaging

120 mL in 1 BOTTLE (83745-185-04)
240 mL in 1 BOTTLE (83745-185-08)
480 mL in 1 BOTTLE (83745-185-16)

source: ndc

Packages (3)

83745-185-04 120 mL in 1 BOTTLE (83745-185-04) 83745-185-08 240 mL in 1 BOTTLE (83745-185-08) 83745-185-16 480 mL in 1 BOTTLE (83745-185-16)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Cetirizine Hydrochloride Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "b350aaa9-197e-4ebc-8315-6ea307dcdb2e", "openfda": {"upc": ["0383745185042", "0383745185165", "0383745185080"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9c6a440b-bd0f-414b-bab3-3b2f57c479d7"], "manufacturer_name": ["APOZEAL PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (83745-185-04)", "package_ndc": "83745-185-04", "marketing_start_date": "20241220"}, {"sample": false, "description": "240 mL in 1 BOTTLE (83745-185-08)", "package_ndc": "83745-185-08", "marketing_start_date": "20241220"}, {"sample": false, "description": "480 mL in 1 BOTTLE (83745-185-16)", "package_ndc": "83745-185-16", "marketing_start_date": "20241220"}], "brand_name": "Cetirizine Hydrochloride Oral Solution", "product_id": "83745-185_b350aaa9-197e-4ebc-8315-6ea307dcdb2e", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83745-185", "generic_name": "Cetirizine Hydrochloride Oral Solution", "labeler_name": "APOZEAL PHARMACEUTICALS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride Oral Solution", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078870", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20271231"}