olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6221
Product ID 60505-6221_ac44fb6f-d383-37f2-9416-6d249604140e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078350
Listing Expiration 2026-12-31
Marketing Start 2022-10-06

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 605056221
Hyphenated Format 60505-6221

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
  • 1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

60505-6221-0 1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0) / 5 mL in 1 BOTTLE, PLASTIC

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": "ac44fb6f-d383-37f2-9416-6d249604140e", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["cc178825-1a4e-6bca-a00d-aa28d5abe589"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "60505-6221-0", "marketing_start_date": "20221006"}], "brand_name": "Olopatadine hydrochloride", "product_id": "60505-6221_ac44fb6f-d383-37f2-9416-6d249604140e", "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": "60505-6221", "generic_name": "Olopatadine hydrochloride", "labeler_name": "Apotex Corp.", "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": "20221006", "listing_expiration_date": "20261231"}