NDC 0023-4291 Lastacaft
Alcaftadine Solution/ Drops Ophthalmic

Product Information

What is NDC 0023-4291?

The NDC code 0023-4291 is assigned by the FDA to the product Lastacaft which is a human over the counter drug product labeled by Allergan, Inc.. The generic name of Lastacaft is alcaftadine. The product's dosage form is solution/ drops and is administered via ophthalmic form. The product is distributed in 5 packages with assigned NDC codes 0023-4291-01 1 bottle, plastic in 1 carton / 1 ml in 1 bottle, plastic, 0023-4291-05 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic, 0023-4291-06 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic, 0023-4291-07 2 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic, 0023-4291-10 2 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0023-4291
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Lastacaft
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Alcaftadine
Product Type 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.		Human Otc Drug
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Allergan, Inc.
Labeler Code0023
FDA Application Number 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.		NDA022134
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		12-01-2021
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Lastacaft?


Product Packages

NDC Code 0023-4291-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 1 mL in 1 BOTTLE, PLASTIC

NDC Code 0023-4291-05

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

NDC Code 0023-4291-06

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

NDC Code 0023-4291-07

Package Description: 2 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

NDC Code 0023-4291-10

Package Description: 2 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

Product Details

What are Lastacaft Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Lastacaft Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Lastacaft Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Lastacaft Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Alcaftadine 0.25%


Purpose



Antihistamine


Use



 Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.


Warnings



For external use only.

Do not use

■ if solution changes color or becomes cloudy. 

■ if you are sensitive to any ingredient in this product. 

■ to treat contact lens related irritation.


When Using This Product



■ do not touch tip of container to any surface to avoid contamination. 

■ remove contact lenses before use. 

■ wait at least 10 minutes before reinserting contact lenses after use. 

■ do not wear a contact lens if your eye is red.


Stop Use And Ask A Doctor If



you experience any of the following:

■ eye pain.

■ changes in vision.

■ increased redness of the eye.

■ itching that worsens or lasts for more than 72 hours.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Adults and children 2 years of age and older: 
    • put 1 drop in the affected eye(s) once daily, no more than once per day.
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product.
    • replace cap after each use.

    • Children under 2 years of age: Consult a doctor.

Other Information



■ Only for use in the eye. 

■ Store at 15°-25°C (59°-77°F).


Inactive Ingredients



benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid.


Questions Or Comments?



telephone icon - lastacaft otc 01

telephone icon - lastacaft otc 01

1.800.678.1605

www.Lastacaft.com


Principal Display Panel



LASTACAFT
Alcaftadine ophthalmic solution 0.25%
Antihistamine Eye Drops
120 DAY SUPPLY
2 bottles (0.17 fl oz (5 mL) each Sterile

LASTACAFTAlcaftadine ophthalmic solution 0.25%Antihistamine Eye Drops120 DAY SUPPLY2 bottles (0.17 fl oz (5 mL) each Sterile - lastacaft otc 02

LASTACAFTAlcaftadine ophthalmic solution 0.25%Antihistamine Eye Drops120 DAY SUPPLY2 bottles (0.17 fl oz (5 mL) each Sterile - lastacaft otc 02

LASTACAFT
Alcaftadine ophthalmic solution 0.25%
Antihistamine Eye Drops
60 DAY SUPPLY
0.17 fl oz (5 mL) Sterile

LASTACAFT
Alcaftadine ophthalmic solution 0.25%
Antihistamine Eye Drops
0.17 fl oz (5 mL) Sterile


* Please review the disclaimer below.