Opcicon One-Step

Opcicon One-Step is an FDA-registered drug product whose active ingredient is LEVONORGESTREL. It is labelled by Sun Pharmaceutical Industries, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 62756-718, application ANDA202635, label effective 20230113. 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, bir control. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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.

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.

5 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.

What is Opcicon One-Step used for?
Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use bir th control)

Who makes Opcicon One-Step?
Sun Pharmaceutical Industries, Inc. is the labeler of record for Opcicon One-Step. 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 Opcicon One-Step 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 Opcicon One-Step 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 Opcicon One-Step been recalled?
5 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.