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Cetirizine HCl

Cetirizine · Kit

Over-the-counter ANDA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Cetirizine HCl
Generic name
Cetirizine
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
GLENMARK THERAPEUTICS INC., USA
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
078427
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 28, 2007
Sponsor
GLENMARK PHARMS
Products on application
2
Submissions recorded
2
Products approved under application 078427.
Product Trade name Form Strength Ingredient Status TE Flags
078427-003 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
078427-004 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 078427.
Type No. Action Status Date Review
Supplement 6 Manufacturing (CMC) Approved April 3, 2025 Unknown
Original application 1 Approved December 28, 2007 —

Review documents

  • 0 · Original application · January 9, 2008
  • 0 · Original application · January 8, 2008

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72657-130-05 72657-130 GLENMARK THERAPEUTICS INC., USA 1 KIT in 1 PACKAGE (72657-130-05) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE May 13, 2024
72657-131-89 72657-131 GLENMARK THERAPEUTICS INC., USA 1 KIT in 1 PACKAGE (72657-131-89) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE May 13, 2024
72657-130 72657-130 GLENMARK THERAPEUTICS INC., USA — May 13, 2024
72657-131 72657-131 GLENMARK THERAPEUTICS INC., USA — May 13, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status

Generated September 25, 2026 · 7 sections on this page.