cetirizine hcl

Generic: cetirizine

Labeler: geri-care pharmaceutical corp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hcl
Generic Name cetirizine
Labeler geri-care pharmaceutical corp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
GERI-CARE PHARMACEUTICAL CORP

Identifiers & Regulatory

Product NDC 57896-992
Product ID 57896-992_3389e955-a045-abfd-e063-6394a90a4e02
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076047
Listing Expiration 2026-12-31
Marketing Start 2025-04-24

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 57896992
Hyphenated Format 57896-992

Supplemental Identifiers

RxCUI
1014678
UPC
0357896992019
UNII
64O047KTOA

Packaging Origin

Original Packager
true

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 hcl (source: ndc)
Generic Name cetirizine (source: ndc)
Application Number ANDA076047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (57896-992-01)
source: ndc

Packages (1)

57896-992-01 100 TABLET, FILM COATED in 1 BOTTLE (57896-992-01)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3389e955-a045-abfd-e063-6394a90a4e02", "openfda": {"upc": ["0357896992019"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["3389e947-b7d1-6caf-e063-6294a90a2238"], "manufacturer_name": ["GERI-CARE PHARMACEUTICAL CORP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (57896-992-01)", "package_ndc": "57896-992-01", "marketing_start_date": "20250424"}], "brand_name": "Cetirizine HCl", "product_id": "57896-992_3389e955-a045-abfd-e063-6394a90a4e02", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57896-992", "generic_name": "Cetirizine", "labeler_name": "GERI-CARE PHARMACEUTICAL CORP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine HCl", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076047", "marketing_category": "ANDA", "marketing_start_date": "20250424", "listing_expiration_date": "20261231"}