cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: indoco remedies limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler indoco remedies limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-152
Product ID 14445-152_c1a05a6d-3db7-446f-927b-787a062ad1ae
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218895
Listing Expiration 2026-12-31
Marketing Start 2024-10-04

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 14445152
Hyphenated Format 14445-152

Supplemental Identifiers

RxCUI
1014678
UPC
0314445152300
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 ANDA218895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (5)

14445-152-01 1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE 14445-152-03 1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE 14445-152-05 1 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE 14445-152-30 1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE 14445-152-90 1 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "c1a05a6d-3db7-446f-927b-787a062ad1ae", "openfda": {"upc": ["0314445152300"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["2942e093-5077-44d3-b080-8d945d03c55f"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (14445-152-01)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "14445-152-01", "marketing_start_date": "20241004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (14445-152-03)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "14445-152-03", "marketing_start_date": "20241004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (14445-152-05)  / 500 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "14445-152-05", "marketing_start_date": "20241004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (14445-152-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "14445-152-30", "marketing_start_date": "20241004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (14445-152-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "14445-152-90", "marketing_start_date": "20241004"}], "brand_name": "CETIRIZINE HYDROCHLORIDE", "product_id": "14445-152_c1a05a6d-3db7-446f-927b-787a062ad1ae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "14445-152", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CETIRIZINE HYDROCHLORIDE", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA218895", "marketing_category": "ANDA", "marketing_start_date": "20241004", "listing_expiration_date": "20261231"}