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LORATADINE

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
LORATADINE
Generic name
Loratadine
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr. Reddy's Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
12
Packages
33
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Loratadine 10 mg/1 311372 View
Loratadine 5 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
45

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213294
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 30, 2020
Sponsor
INSTAPILL
Products on application
1
Submissions recorded
1
Products approved under application 213294.
Product Trade name Form Strength Ingredient Status TE Flags
213294-001 LORATADINE TABLET, ORALLY DISINTEGRATING LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213294.
Type No. Action Status Date Review
Original application 1 Approved October 30, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260904). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260904 HUMAN OTC DRUG · 20260105 HUMAN OTC DRUG · 20240507 HUMAN OTC DRUG · 20230625

Indications and Usage

openFDA Drug Labeling

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

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions Place 1 tablet on tongue; tablet disentigrates with or without water. adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers who have liver or kidney disease ask a doctor

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

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each tablet) Purpose Loratadine USP, 10 mg............................................................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 a 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 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 (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet. safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister FDA approved acceptance criteria for assay and organic impurities differs from USP test Inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate Questions or comments? Advagen - 866-488-0312 Distributed by: Advagen Pharma Ltd East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd., Thane 421506, India. Rev. 02, 11/24

Adverse event reports

Source: openFDA FAERS
114,194
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LORATADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72888-029-09 72888-029 Advagen Pharma Limited 1 BLISTER PACK in 1 CARTON (72888-029-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK September 10, 2020
72888-029-11 72888-029 Advagen Pharma Limited 3 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK September 10, 2020
59651-074-49 59651-074 Aurobindo Pharma Limited 4000 TABLET, ORALLY DISINTEGRATING in 1 BAG (59651-074-49) April 11, 2018
62938-0004-1 62938-0004 CATALENT U.K. SWINDON ZYDIS LIMITED 3024 BLISTER PACK in 1 BOX (62938-0004-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 12, 2006
62938-0004-2 62938-0004 CATALENT U.K. SWINDON ZYDIS LIMITED 3024 BLISTER PACK in 1 BOX (62938-0004-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 12, 2006
62938-0004-3 62938-0004 CATALENT U.K. SWINDON ZYDIS LIMITED 3024 BLISTER PACK in 1 BOX (62938-0004-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK January 30, 2023
62938-0005-2 62938-0005 CATALENT U.K. SWINDON ZYDIS LIMITED 3024 BLISTER PACK in 1 BOX (62938-0005-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
62938-0005-3 62938-0005 CATALENT U.K. SWINDON ZYDIS LIMITED 3024 BLISTER PACK in 1 BOX (62938-0005-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
51316-502-01 51316-502 CVS PHARMACY, INC 1 BLISTER PACK in 1 CARTON (51316-502-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-502-02 51316-502 CVS PHARMACY, INC 2 BLISTER PACK in 1 CARTON (51316-502-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-502-03 51316-502 CVS PHARMACY, INC 3 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-502-04 51316-502 CVS PHARMACY, INC 4 BLISTER PACK in 1 CARTON (51316-502-04) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-502-05 51316-502 CVS PHARMACY, INC 5 BLISTER PACK in 1 CARTON (51316-502-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-502-06 51316-502 CVS PHARMACY, INC 6 BLISTER PACK in 1 CARTON (51316-502-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 31, 2021
51316-503-01 51316-503 CVS PHARMACY, INC 1 BLISTER PACK in 1 CARTON (51316-503-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
51316-503-02 51316-503 CVS PHARMACY, INC 2 BLISTER PACK in 1 CARTON (51316-503-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
51316-503-03 51316-503 CVS PHARMACY, INC 3 BLISTER PACK in 1 CARTON (51316-503-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
51316-503-04 51316-503 CVS PHARMACY, INC 4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
51316-503-05 51316-503 CVS PHARMACY, INC 5 BLISTER PACK in 1 CARTON (51316-503-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
51316-503-06 51316-503 CVS PHARMACY, INC 6 BLISTER PACK in 1 CARTON (51316-503-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 8, 2021
43598-707-30 43598-707 Dr. Reddy's Laboratories Inc. 3 BLISTER PACK in 1 CARTON (43598-707-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK July 1, 2023
43598-758-10 43598-758 Dr. Reddy's Laboratories Inc. 1 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK July 1, 2023
43598-758-30 43598-758 Dr. Reddy's Laboratories Inc. 3 BLISTER PACK in 1 CARTON (43598-758-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK July 1, 2023
11822-0558-0 11822-0558 Rite Aid Corporation 30 BLISTER PACK in 1 CARTON (11822-0558-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK July 17, 2020
59556-917-01 59556-917 Strides Pharma Inc 1 BLISTER PACK in 1 CARTON (59556-917-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
59556-917-02 59556-917 Strides Pharma Inc 2 BLISTER PACK in 1 CARTON (59556-917-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
59556-917-03 59556-917 Strides Pharma Inc 3 BLISTER PACK in 1 CARTON (59556-917-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
59556-917-04 59556-917 Strides Pharma Inc 4 BLISTER PACK in 1 CARTON (59556-917-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
59556-917-05 59556-917 Strides Pharma Inc 5 BLISTER PACK in 1 CARTON (59556-917-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
59556-917-06 59556-917 Strides Pharma Inc 6 BLISTER PACK in 1 CARTON (59556-917-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 10, 2021
72983-501-01 72983-501 Tenshi Kaizen Pvt Ltd 1 BLISTER PACK in 1 CARTON (72983-501-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK May 19, 2021
72983-501-03 72983-501 Tenshi Kaizen Pvt Ltd 3 BLISTER PACK in 1 CARTON (72983-501-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK May 19, 2021
72983-503-06 72983-503 Tenshi Kaizen Pvt Ltd 60 BLISTER PACK in 1 CARTON (72983-503-06) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK May 7, 2024
72888-029 72888-029 Advagen Pharma Limited — September 10, 2020
59651-074 59651-074 Aurobindo Pharma Limited — April 11, 2018
62938-0004 62938-0004 CATALENT U.K. SWINDON ZYDIS LIMITED — December 12, 2006
62938-0005 62938-0005 CATALENT U.K. SWINDON ZYDIS LIMITED — November 27, 2002
51316-502 51316-502 CVS PHARMACY, INC — December 31, 2021
51316-503 51316-503 CVS PHARMACY, INC — August 8, 2021
43598-707 43598-707 Dr. Reddy's Laboratories Inc. — May 19, 2021
43598-758 43598-758 Dr. Reddy's Laboratories Inc. — May 19, 2021
11822-0558 11822-0558 Rite Aid Corporation — July 17, 2020
59556-917 59556-917 Strides Pharma Inc — August 10, 2021
72983-501 72983-501 Tenshi Kaizen Pvt Ltd — May 19, 2021
72983-503 72983-503 Tenshi Kaizen Pvt Ltd — May 7, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.