olopatadine hydrochloride ophthalmic solution (68083-398)

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 7 mg/mL

Manufacturer

Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-398

Product ID 68083-398_e05ea1df-8db8-4261-be59-8f303da3b57e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213514

Listing Expiration 2027-12-31

Marketing Start 2026-01-06

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 68083398

Hyphenated Format 68083-398

Supplemental Identifiers

RxCUI

1601086

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 ANDA213514 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

7 mg/mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

68083-398-01 1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (7 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": "e05ea1df-8db8-4261-be59-8f303da3b57e", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1601086"], "spl_set_id": ["a3475f8c-c780-43c0-b22f-08a0ce5608fd"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-398-01", "marketing_start_date": "20260106"}], "brand_name": "Olopatadine Hydrochloride Ophthalmic Solution", "product_id": "68083-398_e05ea1df-8db8-4261-be59-8f303da3b57e", "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": "68083-398", "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": "7 mg/mL"}], "application_number": "ANDA213514", "marketing_category": "ANDA", "marketing_start_date": "20260106", "listing_expiration_date": "20271231"}