cetirizine hydrochloride 10 mg

Generic: cetirizine hydrochloride 10 mg

Labeler: contract pharmacal corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride 10 mg
Generic Name cetirizine hydrochloride 10 mg
Labeler contract pharmacal corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Contract Pharmacal Corp.

Identifiers & Regulatory

Product NDC 10267-3579
Product ID 10267-3579_3633ac85-4814-e6a7-e063-6294a90a375d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076047
Listing Expiration 2026-12-31
Marketing Start 2025-04-16

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 102673579
Hyphenated Format 10267-3579

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 cetirizine hydrochloride 10 mg (source: ndc)
Generic Name cetirizine hydrochloride 10 mg (source: ndc)
Application Number ANDA076047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (10267-3579-1) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (10267-3579-3) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 100 TABLET, FILM COATED in 1 BOTTLE (10267-3579-4)
  • 365 TABLET, FILM COATED in 1 BOTTLE (10267-3579-6)
  • 1 BOTTLE in 1 CARTON (10267-3579-7) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (5)

10267-3579-1 1 BOTTLE in 1 CARTON (10267-3579-1) / 100 TABLET, FILM COATED in 1 BOTTLE 10267-3579-3 1 BOTTLE in 1 CARTON (10267-3579-3) / 30 TABLET, FILM COATED in 1 BOTTLE 10267-3579-4 100 TABLET, FILM COATED in 1 BOTTLE (10267-3579-4) 10267-3579-6 365 TABLET, FILM COATED in 1 BOTTLE (10267-3579-6) 10267-3579-7 1 BOTTLE in 1 CARTON (10267-3579-7) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3633ac85-4814-e6a7-e063-6294a90a375d", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["84459f11-3405-4a8e-be38-333b7de2a578"], "manufacturer_name": ["Contract Pharmacal Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (10267-3579-1)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "10267-3579-1", "marketing_start_date": "20251231"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (10267-3579-3)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "10267-3579-3", "marketing_start_date": "20251231"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10267-3579-4)", "package_ndc": "10267-3579-4", "marketing_start_date": "20250531"}, {"sample": false, "description": "365 TABLET, FILM COATED in 1 BOTTLE (10267-3579-6)", "package_ndc": "10267-3579-6", "marketing_start_date": "20250416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (10267-3579-7)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "10267-3579-7", "marketing_start_date": "20251231"}], "brand_name": "Cetirizine Hydrochloride 10 mg", "product_id": "10267-3579_3633ac85-4814-e6a7-e063-6294a90a375d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "10267-3579", "generic_name": "Cetirizine Hydrochloride 10 mg", "labeler_name": "Contract Pharmacal Corp.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride 10 mg", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076047", "marketing_category": "ANDA", "marketing_start_date": "20250416", "listing_expiration_date": "20261231"}