cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: ohm laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler ohm laboratories inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
OHM LABORATORIES INC.

Identifiers & Regulatory

Product NDC 51660-066
Product ID 51660-066_1ae46a4b-8176-44fc-bc57-ed9e62c02746
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090142
Listing Expiration 2026-12-31
Marketing Start 2022-07-21

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 51660066
Hyphenated Format 51660-066

Supplemental Identifiers

RxCUI
1014674
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 ANDA090142 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE
source: ndc

Packages (1)

51660-066-30 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE

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": "1ae46a4b-8176-44fc-bc57-ed9e62c02746", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014674"], "spl_set_id": ["97802669-b4bd-4807-b3c1-6c6f5a2b0c67"], "manufacturer_name": ["OHM LABORATORIES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51660-066-30)  / 30 TABLET, CHEWABLE in 1 BOTTLE", "package_ndc": "51660-066-30", "marketing_start_date": "20220721"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "51660-066_1ae46a4b-8176-44fc-bc57-ed9e62c02746", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51660-066", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "OHM LABORATORIES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090142", "marketing_category": "ANDA", "marketing_start_date": "20220721", "listing_expiration_date": "20261231"}