olopatadine hydrochloride ophthalmic solution

Generic: olopatadine hydrochloride ophthalmic solution

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride ophthalmic solution
Generic Name olopatadine hydrochloride ophthalmic solution
Labeler walgreen company
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-0867
Product ID 0363-0867_4614bb8f-4968-ec37-e063-6294a90afea2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206046
Listing Expiration 2026-12-31
Marketing Start 2025-12-22

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 03630867
Hyphenated Format 0363-0867

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 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 (0363-0867-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

0363-0867-01 1 BOTTLE in 1 CARTON (0363-0867-01) / 5 mL in 1 BOTTLE

Ingredients (1)

olopatadine hydrochloride (1 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": "4614bb8f-4968-ec37-e063-6294a90afea2", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["66e76ab2-360c-4738-8424-c89c81007d83"], "manufacturer_name": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0867-01)  / 5 mL in 1 BOTTLE", "package_ndc": "0363-0867-01", "marketing_start_date": "20251222"}], "brand_name": "Olopatadine Hydrochloride Ophthalmic Solution", "product_id": "0363-0867_4614bb8f-4968-ec37-e063-6294a90afea2", "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": "0363-0867", "generic_name": "Olopatadine Hydrochloride Ophthalmic Solution", "labeler_name": "WALGREEN COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine Hydrochloride Ophthalmic Solution", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA206046", "marketing_category": "ANDA", "marketing_start_date": "20251222", "listing_expiration_date": "20261231"}