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Loratadine ODT
Loratadine · Tablet, Orally Disintegrating
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 ODT
Generic name
Loratadine
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
13
Packages
18
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loratadine | 10 mg/1 | 311372 | View |
Forms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
31
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
208477
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 11, 2018
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208477-001 | LORATADINE | TABLET, ORALLY DISINTEGRATING | LORATADINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 25 | Efficacy | Approved | December 8, 2022 | Standard |
| Original application | 1 | Approved | April 11, 2018 | Standard |
Review documents
- 0 · Supplement · December 9, 2022
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260807). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260807
Indications and Usage
openFDA Drug LabelingUses 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
Purpose
openFDA Drug LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections 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
Do Not Use
openFDA Drug LabelingDo not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Loratadine USP 10 mg
Adverse event reports
Source: openFDA FAERS114,194
FAERS reports mentioning this drug
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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 60000-950-83 | 60000-950 | Ahold U.S.A., Inc | 1 BLISTER PACK in 1 CARTON (60000-950-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 46122-539-52 | 46122-539 | Amerisource Bergen | 1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | July 9, 2018 |
| 46122-539-65 | 46122-539 | Amerisource Bergen | 3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | August 10, 2022 |
| 58602-744-83 | 58602-744 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-744-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 58602-744-84 | 58602-744 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-744-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 58602-821-83 | 58602-821 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-821-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 58602-821-84 | 58602-821 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-821-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 58602-830-83 | 58602-830 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-830-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 58602-881-15 | 58602-881 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-881-15) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | June 18, 2022 |
| 21130-221-84 | 21130-221 | Better Living Brands, LLC | 3 BLISTER PACK in 1 CARTON (21130-221-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | September 20, 2023 |
| 69842-085-03 | 69842-085 | CVS Pharmacy, Inc. | 1 BLISTER PACK in 1 CARTON (69842-085-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 69842-085-09 | 69842-085 | CVS Pharmacy, Inc. | 3 BLISTER PACK in 1 CARTON (69842-085-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 68016-088-10 | 68016-088 | Chain Drug Consortium, LLC | 1 BLISTER PACK in 1 CARTON (68016-088-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 53943-035-03 | 53943-035 | DISCOUNT DRUG MART | 1 BLISTER PACK in 1 CARTON (53943-035-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 0536-1367-07 | 0536-1367 | Rugby Laboratories | 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | October 6, 2022 |
| 0363-9937-84 | 0363-9937 | WALGREEN CO. | 3 BLISTER PACK in 1 CARTON (0363-9937-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 49035-806-03 | 49035-806 | Wal-Mart Stores, Inc. | 1 BLISTER PACK in 1 CARTON (49035-806-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 49035-806-09 | 49035-806 | Wal-Mart Stores, Inc. | 3 BLISTER PACK in 1 CARTON (49035-806-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | April 11, 2018 |
| 60000-950 | 60000-950 | Ahold U.S.A., Inc | — | April 11, 2018 |
| 46122-539 | 46122-539 | Amerisource Bergen | — | July 9, 2018 |
| 58602-744 | 58602-744 | Aurohealth LLC | — | April 11, 2018 |
| 58602-821 | 58602-821 | Aurohealth LLC | — | April 11, 2018 |
| 58602-830 | 58602-830 | Aurohealth LLC | — | April 11, 2018 |
| 58602-881 | 58602-881 | Aurohealth LLC | — | June 18, 2022 |
| 21130-221 | 21130-221 | Better Living Brands, LLC | — | September 20, 2023 |
| 69842-085 | 69842-085 | CVS Pharmacy, Inc. | — | April 11, 2018 |
| 68016-088 | 68016-088 | Chain Drug Consortium, LLC | — | April 11, 2018 |
| 53943-035 | 53943-035 | DISCOUNT DRUG MART | — | April 11, 2018 |
| 0536-1367 | 0536-1367 | Rugby Laboratories | — | October 6, 2022 |
| 0363-9937 | 0363-9937 | WALGREEN CO. | — | April 11, 2018 |
| 49035-806 | 49035-806 | Wal-Mart Stores, Inc. | — | April 11, 2018 |
Sources for 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 · 9 sections on this page.