olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler allegiant health
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-480
Product ID 69168-480_94283fa2-f59d-4cfd-9f02-e4aaf60382ca
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078350
Listing Expiration 2026-12-31
Marketing Start 2025-05-05

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 69168480
Hyphenated Format 69168-480

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 (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number ANDA078350 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (69168-480-02) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69168-480-65) / 5 mL in 1 BOTTLE
source: ndc

Packages (2)

69168-480-02 2 BOTTLE in 1 CARTON (69168-480-02) / 5 mL in 1 BOTTLE 69168-480-65 1 BOTTLE in 1 CARTON (69168-480-65) / 5 mL in 1 BOTTLE

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

OLOPATADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "94283fa2-f59d-4cfd-9f02-e4aaf60382ca", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["fdb808ef-9d5f-4bc3-86e7-f519b5c75a46"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (69168-480-02)  / 5 mL in 1 BOTTLE", "package_ndc": "69168-480-02", "marketing_start_date": "20250731"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-480-65)  / 5 mL in 1 BOTTLE", "package_ndc": "69168-480-65", "marketing_start_date": "20250505"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "69168-480_94283fa2-f59d-4cfd-9f02-e4aaf60382ca", "dosage_form": "SOLUTION/ DROPS", "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": "69168-480", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078350", "marketing_category": "ANDA", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}