cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: retail business services,llc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler retail business services,llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
RETAIL BUSINESS SERVICES,LLC.

Identifiers & Regulatory

Product NDC 72476-764
Product ID 72476-764_46518a5f-819b-3a94-e063-6294a90a4533
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2020-04-21

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 72476764
Hyphenated Format 72476-764

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
  • 30 TABLET in 1 BOTTLE (72476-764-03)
  • 14 TABLET in 1 BLISTER PACK (72476-764-16)
  • 120 TABLET in 1 BOTTLE (72476-764-23)
  • 70 TABLET in 1 BOTTLE (72476-764-70)
source: ndc

Packages (4)

72476-764-03 30 TABLET in 1 BOTTLE (72476-764-03) 72476-764-16 14 TABLET in 1 BLISTER PACK (72476-764-16) 72476-764-23 120 TABLET in 1 BOTTLE (72476-764-23) 72476-764-70 70 TABLET in 1 BOTTLE (72476-764-70)

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": "46518a5f-819b-3a94-e063-6294a90a4533", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["9f04520e-161d-3f7b-e053-2a95a90a678d"], "manufacturer_name": ["RETAIL BUSINESS SERVICES,LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72476-764-03)", "package_ndc": "72476-764-03", "marketing_start_date": "20200421"}, {"sample": false, "description": "14 TABLET in 1 BLISTER PACK (72476-764-16)", "package_ndc": "72476-764-16", "marketing_start_date": "20200421"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72476-764-23)", "package_ndc": "72476-764-23", "marketing_start_date": "20200421"}, {"sample": false, "description": "70 TABLET in 1 BOTTLE (72476-764-70)", "package_ndc": "72476-764-70", "marketing_start_date": "20200421"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "72476-764_46518a5f-819b-3a94-e063-6294a90a4533", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72476-764", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "RETAIL BUSINESS SERVICES,LLC.", "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": "20200421", "listing_expiration_date": "20261231"}