Opcicon One-Step 1.5 mg/1

levonorgestrel · TABLET · Sun Pharmaceutical Industries, Inc.

No Recall History

Plain English

Opcicon One-Step is a prescription tablet containing levonorgestrel at 1.5 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name: Opcicon One-Step
Generic Name: levonorgestrel
NDC Code (Product): 62756-718
Manufacturer: Sun Pharmaceutical Industries, Inc.
Strength: 1.5 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status: HUMAN OTC DRUG
Application #: ANDA202635
Drug Class: Inhibit Ovum Fertilization [PE]; Progesterone Congeners [CS]
Marketing Start: 09/12/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective454 reports

nausea195 reports

headache174 reports

genital haemorrhage160 reports

abdominal pain134 reports

dizziness129 reports

fatigue127 reports

maternal exposure during pregnancy122 reports

vaginal haemorrhage119 reports

vomiting111 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Frequently Asked Questions

What is Opcicon One-Step used for?

Opcicon One-Step contains levonorgestrel. It is a tablet taken oral. Consult your doctor for specific uses.

Is Opcicon One-Step a controlled substance?

Opcicon One-Step is not classified as a controlled substance by the DEA.

What is the generic name for Opcicon One-Step?

The generic name for Opcicon One-Step is levonorgestrel. There are 12 other brand versions of levonorgestrel.

What is the NDC code for Opcicon One-Step 1.5 mg/1?

The NDC (National Drug Code) for Opcicon One-Step 1.5 mg/1 is 62756-718, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

62756-718

Package NDC

62756-718-60

Other Levonorgestrel Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)