cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 76162-009
Product ID 76162-009_7baa79c5-be46-4b09-8cae-c306edb7f97a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213557
Listing Expiration 2026-12-31
Marketing Start 2024-06-06

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 76162009
Hyphenated Format 76162-009

Supplemental Identifiers

RxCUI
1011482
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 ANDA213557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (76162-009-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

76162-009-76 4 BLISTER PACK in 1 CARTON (76162-009-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "7baa79c5-be46-4b09-8cae-c306edb7f97a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1011482"], "spl_set_id": ["f4ba3e0c-e6b3-2596-e053-2a95a90ab850"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (76162-009-76)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "76162-009-76", "marketing_start_date": "20240606"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "76162-009_7baa79c5-be46-4b09-8cae-c306edb7f97a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76162-009", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA213557", "marketing_category": "ANDA", "marketing_start_date": "20240606", "listing_expiration_date": "20261231"}