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NDC 58602-0744-83 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 Aurohealth LLC. 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: 58602-0744-83
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	58602-0744
Product ID	58602-744_8f9af970-c068-4d8c-8f90-b32efdd5409a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Aurohealth LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208477
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0744-83 (58602074483)

Pricing Information	N/A
NDC Package Code	58602-744-83
Billing NDC	58602074483
Package	1 BLISTER PACK in 1 CARTON (58602-744-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2018-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8c119b12-f512-4207-b354-7244d1f9963a 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 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 X 10) Orally Disintegrating Tablets

AUROHEALTH

NDC 58602-744-83

**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

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

*When taken as directed. See Drug Facts Panel.

10 (1 X 10) Orally Disintegrating Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 X 10) Orally Disintegrating Tablets

INGREDIENTS AND APPEARANCE

LORATADINE ODT

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-744
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:58602-744-83	1 in 1 CARTON	04/11/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:58602-744-84	3 in 1 CARTON	04/11/2018
2		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	04/11/2018

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-744) , MANUFACTURE(58602-744)

Revised: 11/2022

Document Id: 8f9af970-c068-4d8c-8f90-b32efdd5409a

Set id: 8c119b12-f512-4207-b354-7244d1f9963a

Version: 3

Effective Time: 20221103