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NDC 70000-0583-01 Loratadine 10 mg/1 Details

Loratadine 10 mg/1

Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. 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: 70000-0583-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	70000-0583
Product ID	70000-0583_1b68378d-974a-4931-9677-64bb652eeb84
Associated GPIs	41550030000320
GCN Sequence Number	018698
GCN Sequence Number Description	loratadine TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60563
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Loratadine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208314
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0583-01 (70000058301)

Pricing Information
NDC Package Code	70000-0583-1
Billing NDC	70000058301
Package	2 BLISTER PACK in 1 CARTON (70000-0583-1) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-08-30
NDC Exclude Flag	N
Price Per Unit	0.0607
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ALLERGY RELIEF 10 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
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 c96dd1c9-85a0-0792-e053-2a95a90a2264 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
itchy, watery eyes
sneezing
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

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

Safety sealed: do not use if the individual blister unit is open or torn
store at 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (20 Tablets)

LEADER™

NDC 70000-0583-1

Non-Drowsy* | 24 Hour

Allergy Relief

Loratadine Tablets USP, 10 mg | Antihistamine

Indoor & Outdoor

Allergies

24 Hour Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

COMPARE TO

CLARITIN®

active ingredient**

100% Money

Back Gaurantee

20 TABLETS

Actual Size

*When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0583
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	39;L
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0583-1	2 in 1 CARTON	08/30/2021
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	ANDA208314	08/30/2021

Labeler - Cardinal Health (063997360)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(70000-0583) , MANUFACTURE(70000-0583)

Revised: 10/2021

Document Id: 1b68378d-974a-4931-9677-64bb652eeb84

Set id: c96dd1c9-85a0-0792-e053-2a95a90a2264

Version: 3

Effective Time: 20211006