pataday twice a day relief

Generic: olopatadine hydrochloride

Labeler: alcon laboratories, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pataday twice a day relief
Generic Name olopatadine hydrochloride
Labeler alcon laboratories, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-4274
Product ID 0065-4274_c2f804cb-30d1-40d1-b48e-06889a3e0490
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020688
Listing Expiration 2027-12-31
Marketing Start 2020-02-25

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 00654274
Hyphenated Format 0065-4274

Supplemental Identifiers

RxCUI
1111339 2281304
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 pataday twice a day relief (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number NDA020688 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0065-4274-01 1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

PATADAY TWICE A DAY RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c2f804cb-30d1-40d1-b48e-06889a3e0490", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339", "2281304"], "spl_set_id": ["b7a24375-25df-4405-aa7c-34c46af51194"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0065-4274-01", "marketing_start_date": "20200225"}], "brand_name": "PATADAY TWICE A DAY RELIEF", "product_id": "0065-4274_c2f804cb-30d1-40d1-b48e-06889a3e0490", "dosage_form": "SOLUTION", "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": "0065-4274", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PATADAY TWICE A DAY RELIEF", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA020688", "marketing_category": "NDA", "marketing_start_date": "20200225", "listing_expiration_date": "20271231"}