leader olopatadine hydrochloride (70000-0716)

Drug Facts

Product Profile

Brand Name leader olopatadine hydrochloride

Generic Name olopatadine hydrochloride

Labeler cardinal health

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer

CARDINAL HEALTH

Identifiers & Regulatory

Product NDC 70000-0716

Product ID 70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA206087

Listing Expiration 2026-12-31

Marketing Start 2025-04-15

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 700000716

Hyphenated Format 70000-0716

Supplemental Identifiers

RxCUI

1111343

UNII

2XG66W44KF

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 leader olopatadine hydrochloride (source: ndc)

Generic Name olopatadine hydrochloride (source: ndc)

Application Number ANDA206087 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

2 mg/mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1) / 3.5 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

70000-0716-1 1 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1) / 3.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

LEADER OLOPATADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "32c153a7-d51f-72c5-e063-6294a90aee29", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["71d922d2-22a5-4103-a3eb-126094ee8ef5"], "manufacturer_name": ["CARDINAL HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1)  / 3.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70000-0716-1", "marketing_start_date": "20250415"}], "brand_name": "LEADER OLOPATADINE HYDROCHLORIDE", "product_id": "70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29", "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": "70000-0716", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "CARDINAL HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LEADER OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA206087", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}