cetirizine

Generic: cetiirizine

Labeler: cvs pharmacy, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine
Generic Name cetiirizine
Labeler cvs pharmacy, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 51316-764
Product ID 51316-764_465428ca-3000-a730-e063-6394a90a1af4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2023-10-16

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 51316764
Hyphenated Format 51316-764

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 (source: ndc)
Generic Name cetiirizine (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 365 TABLET in 1 BOTTLE (51316-764-65)
source: ndc

Packages (1)

51316-764-65 365 TABLET in 1 BOTTLE (51316-764-65)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "465428ca-3000-a730-e063-6394a90a1af4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["fd8f495a-9940-363b-e053-6294a90a1097"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 BOTTLE (51316-764-65)", "package_ndc": "51316-764-65", "marketing_start_date": "20231016"}], "brand_name": "Cetirizine", "product_id": "51316-764_465428ca-3000-a730-e063-6394a90a1af4", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51316-764", "generic_name": "Cetiirizine", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20231016", "listing_expiration_date": "20261231"}