cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0874
Product ID 0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078412
Listing Expiration 2026-12-31
Marketing Start 2024-02-12

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 01210874
Hyphenated Format 0121-0874

Supplemental Identifiers

RxCUI
1014673
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 ANDA078412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (0121-0874-04)
  • 480 mL in 1 BOTTLE (0121-0874-16)
source: ndc

Packages (2)

0121-0874-04 120 mL in 1 BOTTLE (0121-0874-04) 0121-0874-16 480 mL in 1 BOTTLE (0121-0874-16)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31dc1106-c6ed-4dcd-81e3-206cbd47017b", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["71448ab0-e23e-4cf7-940e-7d67e7362fb4"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (0121-0874-04)", "package_ndc": "0121-0874-04", "marketing_start_date": "20240621"}, {"sample": false, "description": "480 mL in 1 BOTTLE (0121-0874-16)", "package_ndc": "0121-0874-16", "marketing_start_date": "20240212"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0121-0874", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078412", "marketing_category": "ANDA", "marketing_start_date": "20240212", "listing_expiration_date": "20261231"}