olopatadine hydrochloride ophthalmic solution (68083-231)

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride ophthalmic solution

Generic Name olopatadine hydrochloride ophthalmic

Labeler gland pharma limited

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer

Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-231

Product ID 68083-231_9a4c58dc-aee6-441f-8081-608e4fd36193

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209752

Listing Expiration 2026-12-31

Marketing Start 2020-05-20

Pharmacologic Class

Classes

decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083231

Hyphenated Format 68083-231

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 olopatadine hydrochloride ophthalmic solution (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 (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

68083-231-01 1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Olopatadine Hydrochloride Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "9a4c58dc-aee6-441f-8081-608e4fd36193", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["9a4c58dc-aee6-441f-8081-608e4fd36193"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-231-01", "marketing_start_date": "20200520"}], "brand_name": "Olopatadine Hydrochloride Ophthalmic Solution", "product_id": "68083-231_9a4c58dc-aee6-441f-8081-608e4fd36193", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "68083-231", "generic_name": "Olopatadine Hydrochloride Ophthalmic", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine Hydrochloride Ophthalmic Solution", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA209752", "marketing_category": "ANDA", "marketing_start_date": "20200520", "listing_expiration_date": "20261231"}