cetirizine hydrochloride oral solution (68788-8890)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride oral solution

Generic Name cetirizine hydrochloride oral solution

Labeler preferred pharmaceuticals inc.

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8890

Product ID 68788-8890_a03d33dc-a84c-4ab7-88a8-77333bfcb8e7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078870

Listing Expiration 2026-12-31

Marketing Start 2025-06-27

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 687888890

Hyphenated Format 68788-8890

Supplemental Identifiers

RxCUI

1014673

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 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 (68788-8890-1)

source: ndc

Packages (1)

68788-8890-1 120 mL in 1 BOTTLE (68788-8890-1)

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": "a03d33dc-a84c-4ab7-88a8-77333bfcb8e7", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["a03d33dc-a84c-4ab7-88a8-77333bfcb8e7"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (68788-8890-1)", "package_ndc": "68788-8890-1", "marketing_start_date": "20250627"}], "brand_name": "Cetirizine Hydrochloride Oral Solution", "product_id": "68788-8890_a03d33dc-a84c-4ab7-88a8-77333bfcb8e7", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8890", "generic_name": "Cetirizine Hydrochloride Oral Solution", "labeler_name": "Preferred 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": "20250627", "listing_expiration_date": "20261231"}