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Levonorgestrel Tablet, 1.5 mg

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

Levonorgestrel Tablet, 1.5 mg

Generic name

Levonorgestrel Tablet, 1.5 mg

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Strides Pharma Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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
Levonorgestrel	1.5 mg/1	483325	View
Levonorgestrel	1.5 mg/1.5mg	483325	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Inhibit Ovum Fertilization [PE]	PE	All 12 members
Progesterone Congeners [CS]	CS	All 40 members
Progestin [EPC]	EPC	All 40 members
Progestin-containing Intrauterine Device [EPC]	EPC	7 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

202380

Application type

ANDA · Abbreviated New Drug Application

Approval date

May 29, 2015

Sponsor

NAARI PTE

Products on application

Submissions recorded

Products approved under application 202380.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
202380-001	LEVONORGESTREL	TABLET		LEVONORGESTREL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 202380.
Type	No.	Action	Status	Date	Review
Supplement	4	Labeling	Approved	October 25, 2022	Standard
Supplement	1	Labeling	Approved	September 13, 2016	Standard
Original application	1		Approved	May 29, 2015	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20220913). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20220913

Indications and Usage

openFDA Drug Labeling

Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Purpose

openFDA Drug Labeling

Purpose Emergency contraceptive

Dosage and Administration

openFDA Drug Labeling

Directions take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

Warnings

openFDA Drug Labeling

WARNINGS Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

Do Not Use

openFDA Drug Labeling

Do not use if you are already pregnant (because it will not work) for regular birth control

Active Ingredient

openFDA Drug Labeling

Active Ingredient Levonorgestrel 1.5 mg

Adverse event reports

Source: openFDA FAERS

206,324

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: LEVONORGESTREL. 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
45541-1248-1	45541-1248	Gedeon Richter Plc.	1.5 mg in 1 BLISTER PACK (45541-1248-1)	July 10, 2009
59556-282-01	59556-282	Strides Pharma Inc	1 BLISTER PACK in 1 CARTON (59556-282-01) / 1 TABLET in 1 BLISTER PACK	September 13, 2022
45541-1248	45541-1248	Gedeon Richter Plc.	—	July 10, 2009
59556-282	59556-282	Strides Pharma Inc	—	September 13, 2022

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.