olopatadine hydrochloride

Generic: olopatadine hydrochloride

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

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler apotex corp.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

olopatadine hydrochloride 665 ug/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0845
Product ID 60505-0845_312454d0-6465-c4c7-991b-4c4e3bda33c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091572
Listing Expiration 2026-12-31
Marketing Start 2014-10-27

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 605050845
Hyphenated Format 60505-0845

Supplemental Identifiers

RxCUI
1797895
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 ANDA091572 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 665 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (1)

60505-0845-5 1 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE

Ingredients (1)

olopatadine hydrochloride (665 ug/1)

Linked Drug Pages (1)

Olopatadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "312454d0-6465-c4c7-991b-4c4e3bda33c2", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1797895"], "spl_set_id": ["3aa27224-7b72-38eb-0c21-b8d73525ee85"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (60505-0845-5)  / 240 SPRAY, METERED in 1 BOTTLE", "package_ndc": "60505-0845-5", "marketing_start_date": "20141027"}], "brand_name": "Olopatadine Hydrochloride", "product_id": "60505-0845_312454d0-6465-c4c7-991b-4c4e3bda33c2", "dosage_form": "SPRAY, METERED", "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": "60505-0845", "generic_name": "olopatadine hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olopatadine Hydrochloride", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "665 ug/1"}], "application_number": "ANDA091572", "marketing_category": "ANDA", "marketing_start_date": "20141027", "listing_expiration_date": "20261231"}