Levonorgestrel — Tablet

Overview

Brand name

Levonorgestrel

Generic name

Levonorgestrel

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Ohm Laboratories Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

13

Packages

16

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
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

29

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
Progestin-containing Intrauterine System [EPC]	EPC	8 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

202635

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 11, 2014

Sponsor

SUN PHARM

Products on application

1

Submissions recorded

2

Products approved under application 202635.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
202635-001	OPCICON ONE-STEP	TABLET		LEVONORGESTREL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 202635.
Type	No.	Action	Status	Date	Review
Supplement	1	Labeling	Approved	May 29, 2016	Standard
Original application	1		Approved	September 11, 2014	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260901). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260901 HUMAN OTC DRUG · 20250404 HUMAN OTC DRUG · 20240906 HUMAN OTC DRUG · 20230905

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

Dosage and Administration

openFDA Drug Labeling

When should I use levonorgestrel tablet 1.5 mg? The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel tablet 1.5 mg is a backup or emergency method of birth control you can use when: • your regular birth control was used incorrectly or failed • you did not use any birth control method

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 if you are already pregnant (because it will not work) for regular birth control Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel. When using this product you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness 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 are already pregnant (because it will not work) ■ for regular birth control Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each tablet) Levonorgestrel USP 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
69230-333-32	69230-333	Camber Consumer Care Inc	1 BLISTER PACK in 1 CARTON (69230-333-32) / 1 TABLET in 1 BLISTER PACK	September 30, 2025
69230-333-33	69230-333	Camber Consumer Care Inc	2 BLISTER PACK in 1 CARTON (69230-333-33) / 1 TABLET in 1 BLISTER PACK	September 30, 2025
69230-333-34	69230-333	Camber Consumer Care Inc	5 BLISTER PACK in 1 CARTON (69230-333-34) / 1 TABLET in 1 BLISTER PACK	September 30, 2025
72657-123-11	72657-123	GLENMARK THERAPEUTICS INC., USA	1 BLISTER PACK in 1 CARTON (72657-123-11) / 1 TABLET in 1 BLISTER PACK	February 9, 2023
45541-1244-1	45541-1244	Gedeon Richter Plc.	1.5 mg in 1 BLISTER PACK (45541-1244-1)	July 10, 2009
70000-0675-1	70000-0675	LEADER/ CARDINAL HEALTH 110, INC.	1 BLISTER PACK in 1 CARTON (70000-0675-1) / 1 TABLET in 1 BLISTER PACK	July 15, 2024
79929-016-01	79929-016	Naari Pte Limited	1 BLISTER PACK in 1 BOX, UNIT-DOSE (79929-016-01) / 1 TABLET in 1 BLISTER PACK	February 16, 2023
40032-622-30	40032-622	Novel Laboratories, Inc.	1 TABLET in 1 CARTON (40032-622-30)	February 15, 2013
51660-723-11	51660-723	Ohm Laboratories Inc.	1 BLISTER PACK in 1 CARTON (51660-723-11) / 1 TABLET in 1 BLISTER PACK	November 1, 2017
51660-999-01	51660-999	Ohm Laboratories Inc.	1 BLISTER PACK in 1 CARTON (51660-999-01) / 1 TABLET in 1 BLISTER PACK	August 13, 2025
51660-999-11	51660-999	Ohm Laboratories Inc.	1 BLISTER PACK in 1 CARTON (51660-999-11) / 1 TABLET in 1 BLISTER PACK	November 1, 2017
0536-1433-63	0536-1433	Rugby Laboratories	1 BLISTER PACK in 1 CARTON (0536-1433-63) / 1 TABLET in 1 BLISTER PACK	May 24, 2024
71713-098-11	71713-098	Thirty Madison Inc.	1 BLISTER PACK in 1 CARTON (71713-098-11) / 1 TABLET in 1 BLISTER PACK	January 2, 2025
70700-164-06	70700-164	Xiromed LLC	1 BLISTER PACK in 1 CARTON (70700-164-06) / 1 TABLET in 1 BLISTER PACK	March 13, 2020
73581-017-01	73581-017	YYBA CORP	1 BLISTER PACK in 1 CARTON (73581-017-01) / 1 TABLET in 1 BLISTER PACK	September 1, 2026
73581-217-01	73581-217	YYBA Corp	1 BLISTER PACK in 1 CARTON (73581-217-01) / 1 TABLET in 1 BLISTER PACK	March 1, 2026
69230-333	69230-333	Camber Consumer Care Inc	—	September 30, 2025
72657-123	72657-123	GLENMARK THERAPEUTICS INC., USA	—	February 9, 2023
45541-1244	45541-1244	Gedeon Richter Plc.	—	July 10, 2009
70000-0675	70000-0675	LEADER/ CARDINAL HEALTH 110, INC.	—	July 15, 2024
79929-016	79929-016	Naari Pte Limited	—	February 16, 2023
40032-622	40032-622	Novel Laboratories, Inc.	—	February 15, 2013
51660-723	51660-723	Ohm Laboratories Inc.	—	November 1, 2017
51660-999	51660-999	Ohm Laboratories Inc.	—	November 1, 2017
0536-1433	0536-1433	Rugby Laboratories	—	May 24, 2024
71713-098	71713-098	Thirty Madison Inc.	—	January 2, 2025
70700-164	70700-164	Xiromed LLC	—	March 13, 2020
73581-017	73581-017	YYBA CORP	—	September 1, 2026
73581-217	73581-217	YYBA Corp	—	March 1, 2026

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.