cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3637
Product ID 0378-3637_5670c6c3-a4ab-4268-917a-99e0579f3079
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076677
Listing Expiration 2026-12-31
Marketing Start 2007-12-27

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 03783637
Hyphenated Format 0378-3637

Supplemental Identifiers

RxCUI
1014676 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 ANDA076677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05)
source: ndc

Packages (2)

0378-3637-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) 0378-3637-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05)

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": "5670c6c3-a4ab-4268-917a-99e0579f3079", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["487ae0f0-320c-4534-b9e2-0e215f167cea"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01)", "package_ndc": "0378-3637-01", "marketing_start_date": "20071227"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05)", "package_ndc": "0378-3637-05", "marketing_start_date": "20071227"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "0378-3637_5670c6c3-a4ab-4268-917a-99e0579f3079", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0378-3637", "generic_name": "cetirizine hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076677", "marketing_category": "ANDA", "marketing_start_date": "20071227", "listing_expiration_date": "20261231"}