eye allergy itch relief (70000-0053)

Drug Facts

Product Profile

Brand Name eye allergy itch relief

Generic Name olopatadine hydrochloride ophthalmic

Labeler cardinal health 110, llc. dba leader

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer

CARDINAL HEALTH 110, LLC. DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0053

Product ID 70000-0053_a751380b-de68-03ed-5b9c-15596d15d3bd

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209752

Listing Expiration 2026-12-31

Marketing Start 2021-01-15

Pharmacologic Class

Classes

decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] histamine-1 receptor inhibitor [epc] mast cell stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000053

Hyphenated Format 70000-0053

Supplemental Identifiers

RxCUI

1111343

UNII

2XG66W44KF

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 eye allergy itch relief (source: ndc)

Generic Name olopatadine hydrochloride ophthalmic (source: ndc)

Application Number ANDA209752 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

2 mg/mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

70000-0053-1 1 BOTTLE, PLASTIC in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Eye Allergy Itch Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "a751380b-de68-03ed-5b9c-15596d15d3bd", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["135bb2de-b2c0-6f0c-6204-3acbb48dcfbd"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70000-0053-1)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70000-0053-1", "marketing_start_date": "20210115"}], "brand_name": "Eye Allergy Itch Relief", "product_id": "70000-0053_a751380b-de68-03ed-5b9c-15596d15d3bd", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Histamine-1 Receptor Inhibitor [EPC]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "70000-0053", "generic_name": "Olopatadine Hydrochloride Ophthalmic", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Allergy Itch Relief", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA209752", "marketing_category": "ANDA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}