olopatadine hcl

Generic: olopatadine hydrochloride

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hcl
Generic Name olopatadine hydrochloride
Labeler rugby laboratories
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 7 mg/mL

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1478
Product ID 0536-1478_abf48a68-28f8-d2eb-1a84-acf9159f2f2f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213514
Listing Expiration 2027-12-31
Marketing Start 2026-01-15

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 05361478
Hyphenated Format 0536-1478

Supplemental Identifiers

RxCUI
1601086
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 hcl (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number ANDA213514 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 7 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0536-1478-23) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

0536-1478-23 1 BOTTLE, DROPPER in 1 CARTON (0536-1478-23) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

olopatadine hydrochloride (7 mg/mL)

Linked Drug Pages (1)

Olopatadine Hydrochloride Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "abf48a68-28f8-d2eb-1a84-acf9159f2f2f", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1601086"], "spl_set_id": ["edb068e2-1835-483e-e59c-bcbe13b66d76"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0536-1478-23)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0536-1478-23", "marketing_start_date": "20260115"}], "brand_name": "Olopatadine HCl", "product_id": "0536-1478_abf48a68-28f8-d2eb-1a84-acf9159f2f2f", "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": "0536-1478", "generic_name": "olopatadine hydrochloride", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine HCl", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "7 mg/mL"}], "application_number": "ANDA213514", "marketing_category": "ANDA", "marketing_start_date": "20260115", "listing_expiration_date": "20271231"}