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NDC 00536-1367-07 Loratadine ODT 10 mg/1 Details

Loratadine ODT 10 mg/1

Loratadine ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is LORATADINE.

MedlinePlus Drug Summary

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 sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 00536-1367-07
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	00536-1367
Product ID	0536-1367_f59f3400-da77-4eb7-be02-842071d87fae
Associated GPIs
GCN Sequence Number	030476
GCN Sequence Number Description	loratadine TAB RAPDIS 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60521
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Loratadine ODT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Rugby Laboratories
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208477
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1367-07 (00536136707)

Pricing Information
NDC Package Code	0536-1367-07
Billing NDC	00536136707
Package	3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2022-10-06
NDC Exclude Flag	N
Price Per Unit	0.59737
Pricing Unit	EA
Effective Date	2024-01-17
NDC Description	LORATADINE 10 MG ODT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL f59f3400-da77-4eb7-be02-842071d87fae Details

Drug Facts

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
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

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 (1-800-222-1222) right away.

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
do not use if the individual blister unit is open or torn
store at 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
Complies with USP test 2 for Disintegration

Inactive ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

call 1-800-616-2471

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets

Rugby®

NDC 0536-1367-07

Compare to the

active ingredient in

Claritin® RediTabs®**

Original Prescription Strength

Non-Drowsy*

Loratadine Orally Disintegrating

Tablets USP

10 mg



Antihistamine

Indoor & Outdoor Allergies

24 Hour

NO WATER

NEEDED

MELTS IN

YOUR MOUTH

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

30 (3 X 10) Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LORATADINE ODT

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1367
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PEPPERMINT (UNII: V95R5KMY2B)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND (Biconvex)	Size	8mm
Flavor	PEPPERMINT	Imprint Code	K;9
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1367-07	3 in 1 CARTON	10/06/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208477	10/06/2022

Labeler - Rugby Laboratories (079246066)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(0536-1367) , MANUFACTURE(0536-1367)

Revised: 10/2022

Document Id: f59f3400-da77-4eb7-be02-842071d87fae

Set id: f59f3400-da77-4eb7-be02-842071d87fae

Version: 1

Effective Time: 20221006