allergy relief

Generic: cetirizine hydrochloride

Labeler: spirit pharmaceutical llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name cetirizine hydrochloride
Labeler spirit pharmaceutical llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Spirit Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 68210-4230
Product ID 68210-4230_0bde5cd4-6043-3d42-e063-6394a90ac001
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2022-11-16

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 682104230
Hyphenated Format 68210-4230

Supplemental Identifiers

RxCUI
1014678
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 allergy relief (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
  • 120 TABLET, FILM COATED in 1 POUCH (68210-4230-1)
source: ndc

Packages (1)

68210-4230-1 120 TABLET, FILM COATED in 1 POUCH (68210-4230-1)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bde5cd4-6043-3d42-e063-6394a90ac001", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["c9eb5102-5514-4e69-8169-be7341e9fb66"], "manufacturer_name": ["Spirit Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 POUCH (68210-4230-1)", "package_ndc": "68210-4230-1", "marketing_start_date": "20221116"}], "brand_name": "Allergy Relief", "product_id": "68210-4230_0bde5cd4-6043-3d42-e063-6394a90ac001", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68210-4230", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Spirit Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20221116", "listing_expiration_date": "20261231"}