Package 68083-398-01

Brand: olopatadine hydrochloride ophthalmic solution

Generic: olopatadine hydrochloride ophthalmic
NDC Package

Package Facts

Identity

Package NDC 68083-398-01
Digits Only 6808339801
Product NDC 68083-398
Description

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

Marketing

Marketing Status
Marketed Since 2026-01-06
Brand olopatadine hydrochloride ophthalmic solution
Generic olopatadine hydrochloride ophthalmic
Sample Package No

Linked Drug Pages (1)

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"}