SheWise

SheWise is an FDA-registered drug product whose active ingredient is LEVONORGESTREL. It is labelled by GLENMARK THERAPEUTICS INC., USA taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72657-108, application ANDA207044, label effective 20260715. 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.

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.

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

When should I use Levonorgestrel Tablet? The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet within 72 hours (3 days) after you have had unprotected sex . Levonorgestrel Tablet 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 Allergy alert: Do not use if you have ever had an allergic reaction to Levonorgestrel. Sexually transmitted disease (STDs) alert : This product does not protect against HIV/AIDS or other STDs.

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.

What is SheWise 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 SheWise?
GLENMARK THERAPEUTICS INC., USA is the labeler of record for SheWise. 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 SheWise 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 SheWise 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 SheWise been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.