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My Way

levonorgestrel · Tablet

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
My Way
Generic name
levonorgestrel
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
NuCare Pharmaceuticals,Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
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
8

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
201446
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 19, 2014
Sponsor
LUPIN
Products on application
1
Submissions recorded
5
Products approved under application 201446.
Product Trade name Form Strength Ingredient Status TE Flags
201446-001 FALLBACK SOLO TABLET LEVONORGESTREL Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 201446.
Type No. Action Status Date Review
Supplement 9 Labeling Approved May 1, 2026 Standard
Supplement 6 Labeling Approved May 1, 2026 Standard
Supplement 3 Labeling Approved May 1, 2026 Standard
Supplement 2 Labeling Approved May 13, 2016 Standard
Original application 1 Not Applicable Approved June 19, 2014 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250101). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250101 HUMAN OTC DRUG · 20240606 HUMAN OTC DRUG · 20160617

Indications and Usage

openFDA Drug Labeling

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

Purpose Emergency contraceptive

Dosage and Administration

openFDA Drug Labeling

When should I use My Way? The sooner you take emergency contraception, the better it works. You should use My Way within 72 hours (3 days) after you have had unprotected sex . My Way 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 When not to use My Way? My Way should not be used: • as a regular birth control method, because it's not as effective as regular birth control. • if you are already pregnant, because it will not work. • if you are allergic to levonorgestrel or any other ingredients in My Way. When should I talk to a doctor or pharmacist? 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 My Way and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications. How does My Way work? My Way is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. My Way contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that My Way may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb). How can I get the best results from My Way? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take My Way, the better it works . How effective is My Way? If My Way is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant. How will I know My Way worked? You will know My Way has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional. Will I experience any side effects? • some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant. • If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention. • when used as directed, My Way is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. • if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose. What if I still have questions about My Way? If you have questions or need more information, call at 1-800-422-8689 M-F 8:00 am - 5:00 pm or visit our website at www.mywaypill.com. Other Information Keep this and all medication out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Do not use if the seal is opened. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Active Ingredient: levonorgestrel 1.5 mg Inactive Ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone. My Way ® is a registered trademark of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: October 2017 ID#: 253401 If you are sexually active, you should see a healthcare provide …

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 • nausea • lower stomach (abdominal) pain • tiredness • headache • dizziness • breast pain • vomiting

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 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
68180-852-11 68180-852 Lupin Pharmaceuticals, Inc. 1 BLISTER PACK in 1 CARTON (68180-852-11) / 1 TABLET in 1 BLISTER PACK April 25, 2017
43386-622-30 43386-622 Lupin Pharmaceuticals,Inc. 1 TABLET in 1 CARTON (43386-622-30) February 15, 2013
68071-4294-1 68071-4294 NuCare Pharmaceuticals,Inc. 1 TABLET in 1 BOX (68071-4294-1) February 19, 2018
71205-361-01 71205-361 Proficient Rx LP 1 BLISTER PACK in 1 CARTON (71205-361-01) / 1 TABLET in 1 BLISTER PACK November 18, 2019
68180-852 68180-852 Lupin Pharmaceuticals, Inc. — April 25, 2017
43386-622 43386-622 Lupin Pharmaceuticals,Inc. — February 15, 2013
68071-4294 68071-4294 NuCare Pharmaceuticals,Inc. — April 25, 2017
71205-361 71205-361 Proficient Rx LP — April 25, 2017

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.