cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8479
Product ID 0615-8479_1125df7c-ba82-46fe-a411-05322146a3b9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 06158479
Hyphenated Format 0615-8479

Supplemental Identifiers

RxCUI
1014678
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 ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39)
source: ndc

Packages (1)

0615-8479-39 30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39)

Ingredients (1)

cetirizine hydrochloride (10 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": "1125df7c-ba82-46fe-a411-05322146a3b9", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["b53d5e8a-a30c-4025-aa72-d2776a112e3e"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39)", "package_ndc": "0615-8479-39", "marketing_start_date": "20230731"}], "brand_name": "Cetirizine hydrochloride", "product_id": "0615-8479_1125df7c-ba82-46fe-a411-05322146a3b9", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0615-8479", "generic_name": "Cetirizine hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}