cetirizine

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-123
Product ID 71610-123_4528b1ee-ac82-2b33-e063-6294a90a599a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

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 71610123
Hyphenated Format 71610-123

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-123-60)
source: ndc

Packages (1)

71610-123-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-123-60)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4528b1ee-ac82-2b33-e063-6294a90a599a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["4a45672b-67d3-4739-86ec-0a6696dd83d4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-123-60)", "package_ndc": "71610-123-60", "marketing_start_date": "20180817"}], "brand_name": "Cetirizine", "product_id": "71610-123_4528b1ee-ac82-2b33-e063-6294a90a599a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71610-123", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}