NDC 11822-0919 Loratadine
Tablet, Orally Disintegrating Oral

Product Information

What is NDC 11822-0919?

The NDC code 11822-0919 is assigned by the FDA to the product Loratadine which is a human over the counter drug product labeled by Rite Aid Corporation. The product's dosage form is tablet, orally disintegrating and is administered via oral form. The product is distributed in a single package with assigned NDC code 11822-0919-0 30 blister pack in 1 carton / 1 tablet, orally disintegrating 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 Code11822-0919
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
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.
Loratadine
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 FormTablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Rite Aid Corporation
Labeler Code11822
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.
ANDA076011
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.
ANDA - A product marketed under an approved Abbreviated 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.
09-25-2020
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 Loratadine?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)6 MM
Imprint(s)L;L
Score1

Product Packages

NDC Code 11822-0919-0

Package Description: 30 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Product Details

What are Loratadine 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.
  • LORATADINE 10 mg/1 - A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.

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.

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 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

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 (1-800-222-1222).


Directions



  • •place 1 tablet on tongue; tablet disintegrates, with or without water
  • adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
     
     
     
     
     
     

Other Information



  • do not use in printed blister unit is broken or torn
  • •store between 20° to 25°C (68° to 77°F)
  • •use tablet immediately after opening individual blister

Inactive Ingredients



croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredient in Claritin® RediTabs®

FOR JUNIORS & UP AGES 6 YEARS & OLDER

ORIGINAL PRESCRIPTION STRENGTH

LORATADINE

ORALLY DISINTEGRATING TABLETS, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing – Runny nose – Itchy, watery eyes

Itchy throat or nose

24 Hour

ACTUAL SIZE

NO WATER NEEDED

MELTS IN TOUR MOUTH

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

30 TABLETS


* Please review the disclaimer below.