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 TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-128
Product ID 72657-128_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

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 72657128
Hyphenated Format 72657-128

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: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (18)

72657-128-03 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE 72657-128-04 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE 72657-128-08 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE 72657-128-14 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE 72657-128-15 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE 72657-128-18 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE 72657-128-24 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE 72657-128-30 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE 72657-128-35 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE 72657-128-41 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE 72657-128-45 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE 72657-128-60 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE 72657-128-70 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE 72657-128-81 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE 72657-128-82 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE 72657-128-84 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE 72657-128-86 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE 72657-128-90 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 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": "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 BOTTLE in 1 CARTON (72657-128-03)  / 300 TABLET in 1 BOTTLE", "package_ndc": "72657-128-03", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-04)  / 400 TABLET in 1 BOTTLE", "package_ndc": "72657-128-04", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-08)  / 120 TABLET in 1 BOTTLE", "package_ndc": "72657-128-08", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-14)  / 140 TABLET in 1 BOTTLE", "package_ndc": "72657-128-14", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-15)  / 150 TABLET in 1 BOTTLE", "package_ndc": "72657-128-15", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-18)  / 180 TABLET in 1 BOTTLE", "package_ndc": "72657-128-18", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-24)  / 240 TABLET in 1 BOTTLE", "package_ndc": "72657-128-24", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "72657-128-30", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-35)  / 365 TABLET in 1 BOTTLE", "package_ndc": "72657-128-35", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-41)  / 14 TABLET in 1 BOTTLE", "package_ndc": "72657-128-41", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-45)  / 45 TABLET in 1 BOTTLE", "package_ndc": "72657-128-45", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-60)  / 60 TABLET in 1 BOTTLE", "package_ndc": "72657-128-60", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-70)  / 70 TABLET in 1 BOTTLE", "package_ndc": "72657-128-70", "marketing_start_date": "20240513"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (72657-128-81)  / 60 TABLET in 1 BOTTLE", "package_ndc": "72657-128-81", "marketing_start_date": "20240513"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (72657-128-82)  / 70 TABLET in 1 BOTTLE", "package_ndc": "72657-128-82", "marketing_start_date": "20240513"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (72657-128-84)  / 90 TABLET in 1 BOTTLE", "package_ndc": "72657-128-84", "marketing_start_date": "20240513"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (72657-128-86)  / 120 TABLET in 1 BOTTLE", "package_ndc": "72657-128-86", "marketing_start_date": "20240513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72657-128-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "72657-128-90", "marketing_start_date": "20240513"}], "brand_name": "Cetirizine HCl", "product_id": "72657-128_9b19f466-3796-44b8-a637-092926c275f1", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72657-128", "generic_name": "Cetirizine", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine HCl", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078427", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}