cetirizine hcl

Generic: cetirizine

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hcl
Generic Name cetirizine
Labeler glenmark therapeutics inc., usa
Dosage Form KIT
Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-130
Product ID 72657-130_9b19f466-3796-44b8-a637-092926c275f1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078427
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72657130
Hyphenated Format 72657-130

Supplemental Identifiers

RxCUI
1014676 1014678
UPC
0372657128353 0372657129350
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 ANDA078427 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 5 mg
  • 10 mg
source: label
Packaging
  • 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
source: ndc

Packages (1)

72657-130-05 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cetirizine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "9b19f466-3796-44b8-a637-092926c275f1", "openfda": {"upc": ["0372657128353", "0372657129350"], "unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["04b08c52-5390-4cdb-a9e7-fca81fffdc73"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "72657-130-05", "marketing_start_date": "20240513"}], "brand_name": "Cetirizine HCl", "product_id": "72657-130_9b19f466-3796-44b8-a637-092926c275f1", "dosage_form": "KIT", "product_ndc": "72657-130", "generic_name": "Cetirizine", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine HCl", "application_number": "ANDA078427", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}