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Plan B One-Step

levonorgestrel · Tablet

Over-the-counter NDA RLD 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
Plan B One-Step
Generic name
levonorgestrel
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Foundation Consumer Healthcare LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
4
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

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
7

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@FDANDC Directory
Application number
021998
Application type
NDA · New Drug Application
Approval date
July 10, 2009
Sponsor
FDN CONSUMER
Products on application
1
Submissions recorded
6
Products approved under application 021998.
Product Trade name Form Strength Ingredient Status TE Flags
021998-001 PLAN B ONE-STEP TABLET LEVONORGESTREL Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021998.
Type No. Action Status Date Review
Supplement 5 Labeling Approved December 23, 2022 Standard
Supplement 6 Labeling Approved January 4, 2019 Standard
Supplement 4 Labeling Approved August 10, 2017 Standard
Supplement 3 Efficacy Approved June 20, 2013 Standard
Supplement 2 Efficacy Approved April 30, 2013 Standard
Original application 1 Type 3 - New Dosage Form Approved July 10, 2009 Standard

Review documents

  • 0 · Supplement · December 23, 2022
  • 0 · Supplement · December 23, 2022
  • 0 · Supplement · December 23, 2022
  • 0 · Supplement · February 4, 2019
  • 0 · Supplement · January 8, 2019
  • 0 · Supplement · August 15, 2017
  • 0 · Supplement · August 15, 2017
  • 0 · Supplement · November 17, 2015
  • 0 · Supplement · September 24, 2013
  • 0 · Supplement · June 24, 2013
  • 0 · Supplement · June 21, 2013
  • 0 · Supplement · May 2, 2013
  • 0 · Original application · November 24, 2009
  • 0 · Original application · November 24, 2009
  • 0 · Original application · July 13, 2009
  • 0 · Original application · July 13, 2009
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20231024). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231024 HUMAN OTC DRUG · 20230131

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 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.

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-5978 NDC: 50090-5978-0 1 TABLET in a BLISTER PACK / 1 in a BOX, UNIT-DOSE

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
50090-5978-0 50090-5978 A-S Medication Solutions 1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0) / 1 TABLET in 1 BLISTER PACK May 5, 2022
69536-146-19 69536-146 Foundation Consumer Healthcare LLC 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-146-19) / 1 TABLET in 1 BLISTER PACK May 10, 2018
69536-162-88 69536-162 Foundation Consumer Healthcare LLC 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-88) / 1 TABLET in 1 BLISTER PACK May 10, 2018
69536-162-99 69536-162 Foundation Consumer Healthcare LLC 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-99) / 1 TABLET in 1 BLISTER PACK August 15, 2019
50090-5978 50090-5978 A-S Medication Solutions — May 10, 2018
69536-146 69536-146 Foundation Consumer Healthcare LLC — May 10, 2018
69536-162 69536-162 Foundation Consumer Healthcare LLC — May 10, 2018

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 · 11 sections on this page.