cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-821
Product ID 71610-821_15eab1a2-2c02-7134-e063-6394a90af5af
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 71610821
Hyphenated Format 71610-821

Supplemental Identifiers

RxCUI
1014678
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 ANDA077498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-821-30)
  • 90 TABLET in 1 BOTTLE (71610-821-60)
source: ndc

Packages (2)

71610-821-30 30 TABLET in 1 BOTTLE (71610-821-30) 71610-821-60 90 TABLET in 1 BOTTLE (71610-821-60)

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": "15eab1a2-2c02-7134-e063-6394a90af5af", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["15eaa0d1-d18d-72b1-e063-6394a90a8a94"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-821-30)", "package_ndc": "71610-821-30", "marketing_start_date": "20240412"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-821-60)", "package_ndc": "71610-821-60", "marketing_start_date": "20240412"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "71610-821_15eab1a2-2c02-7134-e063-6394a90af5af", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71610-821", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}