Prescription and over-the-counter medicine

Levonorgestrel Brand names: Plan, Mirena, Kyleena, Liletta, Skyla; first approved as Norplant

Levonorgestrel (Plan) is a prescription and over-the-counter medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $6.33 per levonorgestrel 1.5 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the levonorgestrel FDA label on DailyMed (effective January 31, 2023, Foundation Consumer Healthcare LLC); the NDA 19897 record on Drugs@FDA; every levonorgestrel label on DailyMed.

Highlights of the record

FDA label of January 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Forms and strengths

1.5 mg
13.5 mg
19.5 mg
52 mg

Tablet; intrauterine device.

On the market

Earliest approval on file: December 10, 1990 Norplant, Population Council; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 21 first June 24, 2009; 14 with a marketed status in Drugs@FDA
Labelers listed (NDC): 35 of which 31 under generic applications, 4 under brand applications, repackagers included
Last listed patent: September 7, 2040 Liletta system; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $6.33 per tablet Levonorgestrel 1.5 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 3 since 2017 0 Class I among all firms' recalls; latest May 17, 2018
FAERS reports: 200,218 through July 30, 2026

What is levonorgestrel used for?

From the label: indications and usage
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Conditions named in the indications of levonorgestrel's FDA labels, with every medicine labeled for each:

Birth control

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

FDA pharmacologic class: Progestin, Progestin-containing Intrauterine Device and Progestin-containing Intrauterine System.

Source: FDA drug label (Plan B One-Step), Foundation Consumer Healthcare LLC, effective January 31, 2023 (SPL set 6ce6b40e-14ac-47bd-a648-ddf9e452e559), via openFDA; the full label on DailyMed

Is there a generic for levonorgestrel (Plan)?

The FDA approved the first generic levonorgestrel on June 24, 2009. 21 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists levonorgestrel from 31 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Plan B One-Step tablets; a patent listed only for Liletta system runs to September 7, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1990 earliest approval on file
2009 first generic approved
2040 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for levonorgestrel (Plan)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.33 per Levonorgestrel 1.5 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Levonorgestrel 1.5 mg tablet (generic)

$7.00

$5.26

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Econtra one-step 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
Levonorgestrel 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
My choice 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
My way 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
New day 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
Option 2 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	no change
Your choice 1.5 mg tablet	Generic	$6.33 per tablet	$189.92	n/a

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has levonorgestrel been recalled?

The FDA's Enforcement Report lists 3 recalls naming levonorgestrel since 2017: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
May 17, 2018	Class II	Lupin Pharmaceuticals Inc.	Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
June 1, 2017	Class II	L. Perrigo Company	Defective Container: Carton is missing the tablet blister strip and tablet.
April 13, 2017	Class II	Spectrum Laboratory Products, Inc.	CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the levonorgestrel label say about other medicines?

The levonorgestrel label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 36 other medicines name levonorgestrel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Efavirenz	warnings	… (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).
Rifampin	warnings	… 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).

Other labels that name levonorgestrel

Check levonorgestrel against other medicines

Source: FDA drug label (Plan B One-Step), Foundation Consumer Healthcare LLC, effective January 31, 2023 (SPL set 6ce6b40e-14ac-47bd-a648-ddf9e452e559), via openFDA; the full label on DailyMed

What do FAERS reports show for levonorgestrel?

The FDA Adverse Event Reporting System holds 200,218 reports that list levonorgestrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 268 are coded as a death and 10,843 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Device Expulsion45,532
Device Dislocation20,441
Menstruation Irregular15,019
Vaginal Haemorrhage14,923
Genital Haemorrhage11,129
Abdominal Pain Lower9,293
Abdominal Pain (named in the label)8,590
Nausea (named in the label)8,518

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as levonorgestrel?

5 other medicines are given the same way (oral) and in the same FDA class as levonorgestrel or labeled mainly for the same use (birth control), the same class first. Birth control lists all 24 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Ethinyl estradiol and norethindrone	Birth control	15 labelers	$0.181 per tablet 21 1-20 tablet	No current entry
Norethindrone	Birth control	17 labelers	$0.290 per tablet 5 mg tablet	No current entry
Ethinyl estradiol and ferrous fumarate and norethindrone	Birth control	2 labelers	$0.142 per tablet 1.5-30 tablet	No current entry
Ethinyl estradiol and norgestrel	Birth control	2 labelers	$0.302 per tablet 28 tablet	No current entry
Ulipristal	Birth control	none listed	$37.10 per tablet 30 mg tablet	No current entry

Every medicine labeled for the same conditions as levonorgestrel

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does levonorgestrel compare with medicines for the same use?

2 side-by-side pages set levonorgestrel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to levonorgestrel: 5 medicines for the same use
Other progestins: the pharmacologic class, with prices and generics
Levonorgestrel side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other