cetirizine hcl

Generic: cetirizine hcl

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hcl
Generic Name cetirizine hcl
Labeler top care (topco associates llc)
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-542
Product ID 36800-542_27895955-45c0-4a92-e063-6394a90a01cf
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022429
Listing Expiration 2026-12-31
Marketing Start 2024-11-22

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 36800542
Hyphenated Format 36800-542

Supplemental Identifiers

RxCUI
1014675
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 hcl (source: ndc)
Generic Name cetirizine hcl (source: ndc)
Application Number NDA022429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

36800-542-15 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC 36800-542-86 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27895955-45c0-4a92-e063-6394a90a01cf", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["2033e2c3-81af-b1cf-e063-6394a90adbc5"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15)  / 40 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "36800-542-15", "marketing_start_date": "20241122"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86)  / 25 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "36800-542-86", "marketing_start_date": "20241122"}], "brand_name": "Cetirizine HCl", "product_id": "36800-542_27895955-45c0-4a92-e063-6394a90a01cf", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-542", "generic_name": "Cetirizine HCl", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine HCl", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA022429", "marketing_category": "NDA", "marketing_start_date": "20241122", "listing_expiration_date": "20261231"}