cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: bi-mar
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler bi-mar
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Bi-Mar

Identifiers & Regulatory

Product NDC 37835-611
Product ID 37835-611_36d0b7f3-2156-873a-e063-6294a90ac015
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 37835611
Hyphenated Format 37835-611

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
  • 14 TABLET in 1 BOTTLE (37835-611-14)
  • 35 TABLET in 1 BOTTLE (37835-611-35)
  • 90 TABLET in 1 BOTTLE (37835-611-90)
source: ndc

Packages (3)

37835-611-14 14 TABLET in 1 BOTTLE (37835-611-14) 37835-611-35 35 TABLET in 1 BOTTLE (37835-611-35) 37835-611-90 90 TABLET in 1 BOTTLE (37835-611-90)

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": "36d0b7f3-2156-873a-e063-6294a90ac015", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["cbb270c3-34a4-4af8-9da0-2e545787cb55"], "manufacturer_name": ["Bi-Mar"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (37835-611-14)", "package_ndc": "37835-611-14", "marketing_start_date": "20250501"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE (37835-611-35)", "package_ndc": "37835-611-35", "marketing_start_date": "20250501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (37835-611-90)", "package_ndc": "37835-611-90", "marketing_start_date": "20250501"}], "brand_name": "Cetirizine hydrochloride", "product_id": "37835-611_36d0b7f3-2156-873a-e063-6294a90ac015", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37835-611", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Bi-Mar", "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": "20250501", "listing_expiration_date": "20261231"}