olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: walgreen co.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler walgreen co.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
WALGREEN CO.

Identifiers & Regulatory

Product NDC 0363-0200
Product ID 0363-0200_ee463951-4b99-4232-b427-25667231747e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204812
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

Pharmacologic Class

Classes
decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03630200
Hyphenated Format 0363-0200

Supplemental Identifiers

RxCUI
1111339
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 ANDA204812 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0363-0200-40 1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

OLOPATADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "ee463951-4b99-4232-b427-25667231747e", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["637cb721-53bf-4938-80a6-5760980098eb"], "manufacturer_name": ["WALGREEN CO."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0363-0200-40", "marketing_start_date": "20200715"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "0363-0200_ee463951-4b99-4232-b427-25667231747e", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "0363-0200", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "WALGREEN CO.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA204812", "marketing_category": "ANDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}