cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-436
Product ID 68001-436_4262085e-1de6-302e-e063-6394a90a0026
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2020-06-19

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 68001436
Hyphenated Format 68001-436

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 (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68001-436-04) / 30 TABLET in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (68001-436-96) / 10 TABLET in 1 BLISTER PACK (68001-436-16)
  • 1 BOTTLE in 1 CARTON (68001-436-97) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (3)

68001-436-04 1 BOTTLE in 1 CARTON (68001-436-04) / 30 TABLET in 1 BOTTLE 68001-436-96 10 BLISTER PACK in 1 CARTON (68001-436-96) / 10 TABLET in 1 BLISTER PACK (68001-436-16) 68001-436-97 1 BOTTLE in 1 CARTON (68001-436-97) / 300 TABLET in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4262085e-1de6-302e-e063-6394a90a0026", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["a86fbe45-08db-bddf-e053-2a95a90aa792"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-436-04)  / 30 TABLET in 1 BOTTLE", "package_ndc": "68001-436-04", "marketing_start_date": "20200619"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68001-436-96)  / 10 TABLET in 1 BLISTER PACK (68001-436-16)", "package_ndc": "68001-436-96", "marketing_start_date": "20200619"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-436-97)  / 300 TABLET in 1 BOTTLE", "package_ndc": "68001-436-97", "marketing_start_date": "20200619"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "68001-436_4262085e-1de6-302e-e063-6394a90a0026", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68001-436", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20200619", "listing_expiration_date": "20261231"}