cetirizine hydrochloride oral solution (62135-057)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride oral solution

Generic Name cetirizine hydrochloride oral solution

Labeler chartwell rx, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer

Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-057

Product ID 62135-057_06fce480-76eb-a204-e063-6394a90a3bbc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078876

Listing Expiration 2026-12-31

Marketing Start 2012-05-11

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 62135057

Hyphenated Format 62135-057

Supplemental Identifiers

RxCUI

1014673

UPC

0362135057411 0362135057473

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 ANDA078876 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/5mL

source: ndc

Packaging

120 mL in 1 BOTTLE (62135-057-41)
473 mL in 1 BOTTLE (62135-057-47)

source: ndc

Packages (2)

62135-057-41 120 mL in 1 BOTTLE (62135-057-41) 62135-057-47 473 mL in 1 BOTTLE (62135-057-47)

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

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": "06fce480-76eb-a204-e063-6394a90a3bbc", "openfda": {"upc": ["0362135057411", "0362135057473"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["41dc7107-a2d2-4519-ac6f-cbed9f07e9bf"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (62135-057-41)", "package_ndc": "62135-057-41", "marketing_start_date": "20220608"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-057-47)", "package_ndc": "62135-057-47", "marketing_start_date": "20220608"}], "brand_name": "Cetirizine Hydrochloride Oral Solution", "product_id": "62135-057_06fce480-76eb-a204-e063-6394a90a3bbc", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62135-057", "generic_name": "Cetirizine Hydrochloride Oral Solution", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride Oral Solution", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA078876", "marketing_category": "ANDA", "marketing_start_date": "20120511", "listing_expiration_date": "20261231"}