cetirizine

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
VERITYRX, LLC

Identifiers & Regulatory

Product NDC 83939-0003
Product ID 83939-0003_43f4168a-615f-a724-e063-6394a90a24b6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2025-11-03

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 839390003
Hyphenated Format 83939-0003

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
  • 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-0) / 1 TABLET, FILM COATED in 1 POUCH
  • 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-2) / 1 TABLET, FILM COATED in 1 POUCH
  • 100 POUCH in 1 BOX, UNIT-DOSE (83939-0003-3) / 1 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (3)

83939-0003-0 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-0) / 1 TABLET, FILM COATED in 1 POUCH 83939-0003-2 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-2) / 1 TABLET, FILM COATED in 1 POUCH 83939-0003-3 100 POUCH in 1 BOX, UNIT-DOSE (83939-0003-3) / 1 TABLET, FILM COATED in 1 POUCH

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": "43f4168a-615f-a724-e063-6394a90a24b6", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["43f40b92-f0e0-8808-e063-6394a90a656b"], "manufacturer_name": ["VERITYRX, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-0)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0003-0", "marketing_start_date": "20251103"}, {"sample": false, "description": "50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-2)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0003-2", "marketing_start_date": "20251103"}, {"sample": false, "description": "100 POUCH in 1 BOX, UNIT-DOSE (83939-0003-3)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0003-3", "marketing_start_date": "20251103"}], "brand_name": "Cetirizine", "product_id": "83939-0003_43f4168a-615f-a724-e063-6394a90a24b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83939-0003", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "VERITYRX, 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": "20251103", "listing_expiration_date": "20261231"}