NDC 0065-0816 Pataday Once Daily Relief

Pataday Once Daily Relief with NDC 0065-0816 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Pataday Once Daily Relief is olopatadine hydrochloride. The product's dosage form is solution and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1601086 and 2474007.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pataday Once Daily Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

• OLOPATADINE HYDROCHLORIDE 7 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

• BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
• BORIC ACID (UNII: R57ZHV85D4)
• HYDROCHLORIC ACID (UNII: QTT17582CB)
• SODIUM HYDROXIDE (UNII: 55X04QC32I)
• HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN (UNII: P6BYU725IU)
• HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
• MANNITOL (UNII: 3OWL53L36A)
• POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
• POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
• WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

• Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

• Decreased Histamine Release - [PE] (Physiologic Effect)
• Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
• Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA206276 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 09-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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