My Way

LEVONORGESTREL ORAL HUMAN OTC DRUG

My Way is an FDA drug label for the active ingredient LEVONORGESTREL manufactured by Lupin Pharmaceuticals,Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20160617.

Generic name
LEVONORGESTREL
Manufacturer
Lupin Pharmaceuticals,Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
43386-622
Application
ANDA202508
Label effective
20160617

About this product

My Way is an FDA-registered drug product whose active ingredient is LEVONORGESTREL. It is labelled by Lupin Pharmaceuticals,Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 43386-622, application ANDA202508, label effective 20160617. It is one of 25 FDA drug label records sharing the active ingredient LEVONORGESTREL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing LEVONORGESTREL are most often described in connection with: women reduce, chance pregnancy, unprotected sex, contraceptive failed, birth control. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient Levonorgestrel 1.5mg

Indications & Usage

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

Dosage & Administration

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

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

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How products containing LEVONORGESTREL compare

FDA lists 25 drug label records with LEVONORGESTREL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Foundation Consumer Healthcare LLC 4
— — Rapha Pharmaceuticals, Inc. 3
— — GLENMARK THERAPEUTICS INC., USA 2
— — L. Perrigo Company 2
— — SUN PHARMACEUTICAL INDUSTRIES, INC. 2

Recall and safety notices

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0837-2018 My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3. Lupin Pharmaceuticals Inc. Class II Terminated 20180530
D-0838-2018 My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4. Lupin Pharmaceuticals Inc. Class II Terminated 20180530
D-061-2013 Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. Church & Dwight Inc Class II Terminated 20121128

Frequently asked questions

What is My Way used for?
Indications Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Who makes My Way?
Lupin Pharmaceuticals,Inc. is the labeler of record for My Way. 25 FDA label records share the active ingredient LEVONORGESTREL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does My Way come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is My Way prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LEVONORGESTREL?
Yes. 25 FDA drug label records list LEVONORGESTREL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has My Way been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.