olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler bryant ranch prepack
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

olopatadine hydrochloride 665 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8434
Product ID 63629-8434_e659b3d5-5644-4372-a536-5034b9e85621
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 636298434
Hyphenated Format 63629-8434

Supplemental Identifiers

RxCUI
1797895
UNII
2XG66W44KF

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 (63629-8434-1) / 240 SPRAY in 1 BOTTLE
source: ndc

Packages (1)

63629-8434-1 1 BOTTLE in 1 CARTON (63629-8434-1) / 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": "e659b3d5-5644-4372-a536-5034b9e85621", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1797895"], "spl_set_id": ["272e8f56-ee4e-456f-ab98-3e40f657c630"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63629-8434-1)  / 240 SPRAY in 1 BOTTLE", "package_ndc": "63629-8434-1", "marketing_start_date": "20210428"}], "brand_name": "olopatadine hydrochloride", "product_id": "63629-8434_e659b3d5-5644-4372-a536-5034b9e85621", "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": "63629-8434", "generic_name": "Olopatadine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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"}