cetirizine hydrochloride

Generic: cetirizine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-003
Product ID 65162-003_f9d002fa-9c05-4275-a783-053bf1993ca0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090765
Listing Expiration 2026-12-31
Marketing Start 2009-10-07

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 65162003
Hyphenated Format 65162-003

Supplemental Identifiers

RxCUI
1014673
UPC
0365162003864
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 (source: ndc)
Application Number ANDA090765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

65162-003-86 1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE

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": "f9d002fa-9c05-4275-a783-053bf1993ca0", "openfda": {"upc": ["0365162003864"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["7d16ccca-6aa3-4575-9fa7-f57301801a81"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-003-86)  / 118 mL in 1 BOTTLE", "package_ndc": "65162-003-86", "marketing_start_date": "20091007"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "65162-003_f9d002fa-9c05-4275-a783-053bf1993ca0", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65162-003", "generic_name": "Cetirizine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA090765", "marketing_category": "ANDA", "marketing_start_date": "20091007", "listing_expiration_date": "20261231"}