cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: heritage pharma labs inc. d/b/a avet pharmaceuticals labs inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler heritage pharma labs inc. d/b/a avet pharmaceuticals labs inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

Identifiers & Regulatory

Product NDC 23155-929
Product ID 23155-929_ef266d70-f451-4938-b720-2103625cd384
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078876
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 23155929
Hyphenated Format 23155-929

Supplemental Identifiers

RxCUI
1014673
UPC
0323155929515 0323155929522
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 ANDA078876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (23155-929-51)
  • 473 mL in 1 BOTTLE (23155-929-52)
source: ndc

Packages (2)

23155-929-51 120 mL in 1 BOTTLE (23155-929-51) 23155-929-52 473 mL in 1 BOTTLE (23155-929-52)

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Cetirizine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef266d70-f451-4938-b720-2103625cd384", "openfda": {"upc": ["0323155929515", "0323155929522"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["a9b21d71-106e-4bd5-aaab-9254c8a44e0d"], "manufacturer_name": ["Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (23155-929-51)", "package_ndc": "23155-929-51", "marketing_start_date": "20250301"}, {"sample": false, "description": "473 mL in 1 BOTTLE (23155-929-52)", "package_ndc": "23155-929-52", "marketing_start_date": "20250301"}], "brand_name": "Cetirizine hydrochloride", "product_id": "23155-929_ef266d70-f451-4938-b720-2103625cd384", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "23155-929", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA078876", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}