cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: aventura pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler aventura pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Aventura Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69206-990
Product ID 69206-990_3e808491-ec96-4f20-bb5e-3a9e5c72550e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078876
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 69206990
Hyphenated Format 69206-990

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 ANDA078876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (69206-990-01)
source: ndc

Packages (1)

69206-990-01 120 mL in 1 BOTTLE (69206-990-01)

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": "3e808491-ec96-4f20-bb5e-3a9e5c72550e", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["aeb73ab9-3b05-4062-a7fd-352cf2094a56"], "manufacturer_name": ["Aventura Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (69206-990-01)", "package_ndc": "69206-990-01", "marketing_start_date": "20230201"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "69206-990_3e808491-ec96-4f20-bb5e-3a9e5c72550e", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69206-990", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aventura Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078876", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}