cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: granules india ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler granules india ltd
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-764
Product ID 62207-764_2432f862-6d80-666d-e063-6294a90acf74
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2018-05-28

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 62207764
Hyphenated Format 62207-764

Supplemental Identifiers

RxCUI
1014678
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 hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, COATED in 1 BOTTLE (62207-764-49)
  • 14 TABLET, COATED in 1 BOTTLE (62207-764-55)
  • 13 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (3)

62207-764-49 1000 TABLET, COATED in 1 BOTTLE (62207-764-49) 62207-764-55 14 TABLET, COATED in 1 BOTTLE (62207-764-55) 62207-764-73 13 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2432f862-6d80-666d-e063-6294a90acf74", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["6efd5a60-e281-43f9-a52c-a95f46fbcbfc"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (62207-764-49)", "package_ndc": "62207-764-49", "marketing_start_date": "20180528"}, {"sample": false, "description": "14 TABLET, COATED in 1 BOTTLE (62207-764-55)", "package_ndc": "62207-764-55", "marketing_start_date": "20180528"}, {"sample": false, "description": "13 BLISTER PACK in 1 CARTON (62207-764-73)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "62207-764-73", "marketing_start_date": "20180528"}], "brand_name": "Cetirizine hydrochloride", "product_id": "62207-764_2432f862-6d80-666d-e063-6294a90acf74", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62207-764", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Granules India Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20180528", "listing_expiration_date": "20261231"}