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 TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-045
Product ID 65162-045_79a66101-ea46-4515-bb20-ce790b750d70
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078780
Listing Expiration 2026-12-31
Marketing Start 2010-01-21

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 65162045
Hyphenated Format 65162-045

Supplemental Identifiers

RxCUI
1014676
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 ANDA078780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-045-03) / 30 TABLET in 1 BOTTLE
  • 500 TABLET in 1 BOTTLE (65162-045-50)
source: ndc

Packages (2)

65162-045-03 1 BOTTLE in 1 CARTON (65162-045-03) / 30 TABLET in 1 BOTTLE 65162-045-50 500 TABLET in 1 BOTTLE (65162-045-50)

Ingredients (1)

cetirizine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79a66101-ea46-4515-bb20-ce790b750d70", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014676"], "spl_set_id": ["214936a2-adc4-422a-a8fe-4c3ce9e01f36"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-045-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "65162-045-03", "marketing_start_date": "20100121"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-045-50)", "package_ndc": "65162-045-50", "marketing_start_date": "20100121"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "65162-045_79a66101-ea46-4515-bb20-ce790b750d70", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65162-045", "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/1"}], "application_number": "ANDA078780", "marketing_category": "ANDA", "marketing_start_date": "20100121", "listing_expiration_date": "20261231"}