olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

olopatadine hydrochloride 665 ug/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-104
Product ID 45802-104_dca15bfb-d84a-46e3-800c-3e3e1eaa6967
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202853
Listing Expiration 2026-12-31
Marketing Start 2017-06-14

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 45802104
Hyphenated Format 45802-104

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 ANDA202853 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 665 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-104-01) / 240 SPRAY in 1 BOTTLE
source: ndc

Packages (1)

45802-104-01 1 BOTTLE in 1 CARTON (45802-104-01) / 240 SPRAY 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": "dca15bfb-d84a-46e3-800c-3e3e1eaa6967", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1797895"], "spl_set_id": ["126ff6eb-62ae-46f2-ab1e-7ac19346c36b"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-104-01)  / 240 SPRAY in 1 BOTTLE", "package_ndc": "45802-104-01", "marketing_start_date": "20170614"}], "brand_name": "olopatadine hydrochloride", "product_id": "45802-104_dca15bfb-d84a-46e3-800c-3e3e1eaa6967", "dosage_form": "SPRAY", "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": "45802-104", "generic_name": "Olopatadine Hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olopatadine hydrochloride", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "665 ug/1"}], "application_number": "ANDA202853", "marketing_category": "ANDA", "marketing_start_date": "20170614", "listing_expiration_date": "20261231"}