cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8523
Product ID 68788-8523_2b047f42-123a-4fc8-a8cf-fe2820788c12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078398
Listing Expiration 2026-12-31
Marketing Start 2023-09-13

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 687888523
Hyphenated Format 68788-8523

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68788-8523-1) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

68788-8523-1 1 BOTTLE in 1 CARTON (68788-8523-1) / 120 mL in 1 BOTTLE

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": "2b047f42-123a-4fc8-a8cf-fe2820788c12", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["e874264a-becc-45d0-b934-779eab5f5085"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68788-8523-1)  / 120 mL in 1 BOTTLE", "package_ndc": "68788-8523-1", "marketing_start_date": "20230913"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "68788-8523_2b047f42-123a-4fc8-a8cf-fe2820788c12", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8523", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078398", "marketing_category": "ANDA", "marketing_start_date": "20230913", "listing_expiration_date": "20261231"}