eye allergy itch and redness relief

Generic: olopatadine hydrochloride ophthalmic

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye allergy itch and redness relief
Generic Name olopatadine hydrochloride ophthalmic
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0054
Product ID 70000-0054_35a94d69-8b5d-d7c0-4d5e-1590881827e8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209619
Listing Expiration 2026-12-31
Marketing Start 2021-01-15

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 700000054
Hyphenated Format 70000-0054

Supplemental Identifiers

RxCUI
1111339
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 eye allergy itch and redness relief (source: ndc)
Generic Name olopatadine hydrochloride ophthalmic (source: ndc)
Application Number ANDA209619 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70000-0054-1 1 BOTTLE, PLASTIC in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Eye Allergy Itch and Redness Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "35a94d69-8b5d-d7c0-4d5e-1590881827e8", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["5255d142-7d04-ab80-fa97-b11c4486e42c"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70000-0054-1)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70000-0054-1", "marketing_start_date": "20210115"}], "brand_name": "Eye Allergy Itch and Redness Relief", "product_id": "70000-0054_35a94d69-8b5d-d7c0-4d5e-1590881827e8", "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": "70000-0054", "generic_name": "Olopatadine Hydrochloride Ophthalmic", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Allergy Itch and Redness Relief", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA209619", "marketing_category": "ANDA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}