rugby olopatadine hydrochloride ophthalmic solution (0536-1445)

Drug Facts

Product Profile

Brand Name rugby olopatadine hydrochloride ophthalmic solution

Generic Name olopatadine hydrochloride ophthalmic solution

Labeler rugby laboratories

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer

RUGBY LABORATORIES

Identifiers & Regulatory

Product NDC 0536-1445

Product ID 0536-1445_4af71d96-1ace-bb47-e063-6294a90aadaf

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA206046

Listing Expiration 2027-12-31

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 05361445

Hyphenated Format 0536-1445

Supplemental Identifiers

RxCUI

1111339

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 rugby olopatadine hydrochloride ophthalmic solution (source: ndc)

Generic Name olopatadine hydrochloride ophthalmic solution (source: ndc)

Application Number ANDA206046 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

1 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (0536-1445-40) / 5 mL in 1 BOTTLE

source: ndc

Packages (1)

0536-1445-40 1 BOTTLE in 1 CARTON (0536-1445-40) / 5 mL in 1 BOTTLE

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Rugby Olopatadine Hydrochloride Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "4af71d96-1ace-bb47-e063-6294a90aadaf", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["96ad3623-f7cc-4c1c-aa65-d89077873b69"], "manufacturer_name": ["RUGBY LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0536-1445-40)  / 5 mL in 1 BOTTLE", "package_ndc": "0536-1445-40", "marketing_start_date": "20250415"}], "brand_name": "Rugby Olopatadine Hydrochloride Ophthalmic Solution", "product_id": "0536-1445_4af71d96-1ace-bb47-e063-6294a90aadaf", "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": "0536-1445", "generic_name": "Olopatadine Hydrochloride Ophthalmic Solution", "labeler_name": "RUGBY LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rugby Olopatadine Hydrochloride Ophthalmic Solution", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA206046", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20271231"}