Loratadine 10 mg — Tablet

Overview

Brand name

Loratadine 10 mg

Generic name

Loratadine 10 mg

Dosage form

Tablet

Route

—

Marketing category

DRUG FOR FURTHER PROCESSING · BULK API

Labeler

Prodose, Inc.

Product type

Drug For Further Processing

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

Data completeness

76% 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

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

—

Presentations

4

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

219223

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 21, 2024

Sponsor

MARKSANS PHARMA

Products on application

1

Submissions recorded

1

Products approved under application 219223.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
219223-001	LORATADINE	TABLET		LORATADINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 219223.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	November 21, 2024	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250124). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250124

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

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

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

Warnings

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Loratadine USP, 10 mg

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
68210-4122-1	68210-4122	Prodose, Inc.	12 BOTTLE in 1 BOX (68210-4122-1) / 8000 TABLET in 1 BOTTLE (68210-4122-0)	January 19, 2021
49483-732-65	49483-732	TIME CAP LABORATORIES, INC.	365 TABLET in 1 BOTTLE (49483-732-65)	January 25, 2025
68210-4122	68210-4122	Prodose, Inc.	—	January 19, 2021
49483-732	49483-732	TIME CAP LABORATORIES, INC.	—	January 25, 2025

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 · 9 sections on this page.