cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: marlex pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler marlex pharmaceuticals, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 10135-762
Product ID 10135-762_3f7dc523-2934-780a-e063-6294a90a837f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077498
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

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 10135762
Hyphenated Format 10135-762

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA077498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-762-01)
  • 300 TABLET in 1 BOTTLE (10135-762-03)
  • 500 TABLET in 1 BOTTLE (10135-762-05)
  • 30 TABLET in 1 BOTTLE (10135-762-30)
  • 90 TABLET in 1 BOTTLE (10135-762-90)
source: ndc

Packages (5)

10135-762-01 100 TABLET in 1 BOTTLE (10135-762-01) 10135-762-03 300 TABLET in 1 BOTTLE (10135-762-03) 10135-762-05 500 TABLET in 1 BOTTLE (10135-762-05) 10135-762-30 30 TABLET in 1 BOTTLE (10135-762-30) 10135-762-90 90 TABLET in 1 BOTTLE (10135-762-90)

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": "3f7dc523-2934-780a-e063-6294a90a837f", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["eb917099-fecf-6b55-e053-2995a90aaafa"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-762-01)", "package_ndc": "10135-762-01", "marketing_start_date": "20221001"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (10135-762-03)", "package_ndc": "10135-762-03", "marketing_start_date": "20221001"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10135-762-05)", "package_ndc": "10135-762-05", "marketing_start_date": "20221001"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (10135-762-30)", "package_ndc": "10135-762-30", "marketing_start_date": "20221001"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (10135-762-90)", "package_ndc": "10135-762-90", "marketing_start_date": "20221001"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "10135-762_3f7dc523-2934-780a-e063-6294a90a837f", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "10135-762", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Marlex Pharmaceuticals, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077498", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}