NDC 53808-0457 Loratadine

Product Information

What is NDC 53808-0457?

The NDC code 53808-0457 is assigned by the FDA to the product Loratadine which is product labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 53808-0457-1 30 tablet in 1 blister pack . 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 Code53808-0457
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.
Loratadine
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
State Of Florida Doh Central Pharmacy
Labeler Code53808
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.
07-01-2009
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.
12-31-2018
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".
I
NDC Code Structure

What are the uses for Loratadine?


Product Characteristics

Color(s)WHITE (C48325)
ShapeOVAL (C48345)
Size(s)6 MM
Imprint(s)L612
Score1

Product Packages

NDC Code 53808-0457-1

Package Description: 30 TABLET in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Loratadine 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:

Loratadine 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.

* Please review the disclaimer below.

Patient Education

Loratadine

Loratadine is pronounced as (lor at' a deen)

Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]

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Loratadine 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 (In Each Tablet)



Loratadine, USP 10 mg


Purpose



Antihistamine


Uses



Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

How Supplied



They are supplied by State of Florida DOH Central Pharmacy as follows:

NDCStrengthQuantity/FormColorSource Prod. Code
53808-0457-110 mg30 Tablets in a Blister PackWHITE45802-0650

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients.


Ask A Doctor Before Use If You Have



liver or kidney disease.Your doctor should determine if you need a different dose.


When Using This Product



do not take more than directed. Taking more than directed may cause drowsiness.


Stop Use And Ask A Doctor



if an allergic reaction to this product occurs. Seek medical help right away.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information



  • Safety sealed: do not use if the imprinted bottle seal is open or torn.

Inactive Ingredients



Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.


Questions Or Comments?



1 800 719-9260


10 Mg Label



NDC 53808-0457-1 Non-Drowsy*

LORAtadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery

Eyes

• Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.


* Please review the disclaimer below.