cetirizine hydrochloride

Generic: cetirizine hydrochloride tablets

Labeler: verityrx, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride tablets
Labeler verityrx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
VERITYRX, LLC

Identifiers & Regulatory

Product NDC 83939-0004
Product ID 83939-0004_42780c27-b003-a427-e063-6394a90ace93
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078343
Listing Expiration 2026-12-31
Marketing Start 2018-12-17

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 839390004
Hyphenated Format 83939-0004

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 tablets (source: ndc)
Application Number ANDA078343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 TABLET, FILM COATED in 1 POUCH (83939-0004-1)
  • 50 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2) / 1 TABLET, FILM COATED in 1 POUCH
  • 100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3) / 1 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (3)

83939-0004-1 1 TABLET, FILM COATED in 1 POUCH (83939-0004-1) 83939-0004-2 50 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2) / 1 TABLET, FILM COATED in 1 POUCH 83939-0004-3 100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3) / 1 TABLET, FILM COATED in 1 POUCH

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": "42780c27-b003-a427-e063-6394a90ace93", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["42778a1c-6894-8646-e063-6294a90a6cb5"], "manufacturer_name": ["VERITYRX, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 POUCH (83939-0004-1)", "package_ndc": "83939-0004-1", "marketing_start_date": "20251110"}, {"sample": false, "description": "50 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0004-2", "marketing_start_date": "20251103"}, {"sample": false, "description": "100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0004-3", "marketing_start_date": "20251103"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "83939-0004_42780c27-b003-a427-e063-6394a90ace93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83939-0004", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "VERITYRX, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20181217", "listing_expiration_date": "20261231"}