olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

olopatadine hydrochloride 665 ug/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-890
Product ID 65162-890_270f118a-97b1-420b-8504-bfc600008903
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210901
Listing Expiration 2026-12-31
Marketing Start 2020-02-03

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 65162890
Hyphenated Format 65162-890

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 ANDA210901 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 665 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

65162-890-23 1 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY

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": "270f118a-97b1-420b-8504-bfc600008903", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1797895"], "spl_set_id": ["806e8d0f-ff42-4d6e-b840-49e3bf867cb5"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (65162-890-23)  / 665 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "65162-890-23", "marketing_start_date": "20200203"}], "brand_name": "Olopatadine Hydrochloride", "product_id": "65162-890_270f118a-97b1-420b-8504-bfc600008903", "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": "65162-890", "generic_name": "Olopatadine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olopatadine Hydrochloride", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "665 ug/1"}], "application_number": "ANDA210901", "marketing_category": "ANDA", "marketing_start_date": "20200203", "listing_expiration_date": "20261231"}