cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4914
Product ID 63629-4914_3db925ae-d07d-4da4-9dab-155db44d75a0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077829
Listing Expiration 2026-12-31
Marketing Start 2009-10-01

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 636294914
Hyphenated Format 63629-4914

Supplemental Identifiers

RxCUI
1014676
UNII
64O047KTOA

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 ANDA077829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63629-4914-1)
source: ndc

Packages (1)

63629-4914-1 30 TABLET in 1 BOTTLE (63629-4914-1)

Ingredients (1)

cetirizine hydrochloride (5 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": "3db925ae-d07d-4da4-9dab-155db44d75a0", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014676"], "spl_set_id": ["ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-4914-1)", "package_ndc": "63629-4914-1", "marketing_start_date": "20130219"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "63629-4914_3db925ae-d07d-4da4-9dab-155db44d75a0", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63629-4914", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA077829", "marketing_category": "ANDA", "marketing_start_date": "20091001", "listing_expiration_date": "20261231"}