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Opill
norgestrel · Tablet
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Norgestrel | .075 mg/1 | 203717 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 017031-001 | OPILL | TABLET | NORGESTREL | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Code | Expires | Product |
|---|---|---|
| RTO | July 13, 2026 | 001 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 44 | Labeling | Approved | September 24, 2025 | Standard |
| Supplement | 43 | Labeling | Approved | March 11, 2024 | Standard |
| Supplement | 42 | Labeling | Approved | March 11, 2024 | Standard |
| Supplement | 41 | Efficacy | Approved | July 13, 2023 | Standard |
| Supplement | 36 | Labeling | Approved | August 15, 2017 | Standard |
| Supplement | 35 | Labeling | Approved | August 15, 2017 | Standard |
| Supplement | 34 | Labeling | Approved | July 20, 2004 | Standard |
| Supplement | 31 | Manufacturing (CMC) | Approved | March 6, 2002 | Standard |
| Supplement | 30 | Manufacturing (CMC) | Approved | July 8, 1998 | Standard |
| Supplement | 27 | Labeling | Approved | January 18, 1996 | Standard |
| Supplement | 26 | Labeling | Approved | November 29, 1994 | Standard |
| Supplement | 25 | Manufacturing (CMC) | Approved | January 21, 1993 | Standard |
| Supplement | 24 | Labeling | Approved | August 19, 1992 | — |
| Supplement | 23 | Manufacturing (CMC) | Approved | October 6, 1988 | Standard |
| Supplement | 22 | Manufacturing (CMC) | Approved | September 1, 1988 | Standard |
| Supplement | 20 | Manufacturing (CMC) | Approved | April 7, 1987 | Standard |
| Supplement | 19 | Labeling | Approved | October 16, 1985 | — |
| Supplement | 18 | Labeling | Approved | May 3, 1984 | — |
| Supplement | 17 | Labeling | Approved | December 22, 1983 | — |
| Supplement | 15 | Manufacturing (CMC) | Approved | June 3, 1982 | Standard |
| Supplement | 11 | Manufacturing (CMC) | Approved | April 15, 1980 | Standard |
| Supplement | 7 | Labeling | Approved | November 20, 1978 | — |
| Supplement | 4 | Labeling | Approved | December 8, 1977 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | August 15, 1977 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | December 1, 1976 | Standard |
| Supplement | 2 | Manufacturing (CMC) | Approved | January 15, 1976 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | October 23, 1973 | Standard |
Review documents
- 0 · Supplement · September 26, 2025
- 0 · Supplement · September 26, 2025
- Environmental Assessment · Supplement · August 20, 2024
- 0 · Supplement · March 12, 2024
- 0 · Supplement · March 12, 2024
- 0 · Supplement · July 13, 2023
- 0 · Supplement · July 13, 2023
- 0 · Supplement · July 13, 2023
- 0 · Supplement · July 13, 2023
- 0 · Supplement · August 29, 2017
- 0 · Supplement · August 29, 2017
- 0 · Supplement · August 16, 2017
- 0 · Supplement · August 16, 2017
- 0 · Supplement · July 21, 2004
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250127). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse To prevent pregnancy
Purpose
openFDA Drug LabelingPurpose Daily Oral Contraceptive
Dosage and Administration
openFDA Drug LabelingDirections • take 1 tablet at the same time every day • this product will work best to prevent pregnancy when taken exactly as directed • you can start on any day of the month • use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start working See the enclosed leaflet for more information on how to switch from another contraceptive method. • never skip your daily tablet • to prevent pregnancy, take this product every day, even when you bleed or have spotting • when you finish this pack, start the next one the following day without a break • if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days: • take 1 tablet immediately, as soon as you remember that you missed it • then go back to taking your daily tablet at your usual time • use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again • if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed • you should continue to see your healthcare provider(s) for routine healthcare visits When to use a condom (or another barrier method) • every time you have sex for the next 2 days (48 hours): • after you start your first pack of this product • if you take a tablet more than 3 hours late or miss a tablet on 1 or more days • if you vomit or have a severe diarrhea within 4 hours of taking a tablet
Warnings
openFDA Drug LabelingWarnings Allergy alert: Do not use if you are allergic to this product or any of its ingredients, such as FD&C yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy too. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs. Do not use • if you have or ever had breast cancer • if you are already pregnant or think you may be pregnant • together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) • as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex • if you are male Ask a doctor before use if • you currently have vaginal bleeding between your periods and you have not already talked to a doctor • you have liver problems • you have or ever had any cancer Ask doctor or pharmacist before use if • you are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension • you are taking a supplement containing St John’s Wort (an herbal ingredient) • if you have taken ulipristal acetate (an emergency contraceptive, or morning after pill) in the past 5 days See the enclosed leaflet for a detailed list of medicines that may interact with this product. When using this product • you are likely to experience changes in your menstrual periods, such as irregular periods, spotting or bleeding between your periods, or you may stop having periods. To prevent pregnancy, keep taking the product. • you may experience headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating • talk to a doctor (but continue taking every day) if • you have repeated vaginal bleeding brought on by sex • you start having periods that last more than 8 days or are unusually heavy • you start having migraines with aura (headaches that start with changes in vision) or your migraine headaches get worse • take a pregnancy test or talk to a doctor if • your period is late after missing any tablets in the last month • you have not had a period for 2 months or think you may be pregnant Seek medical help right away if • you have sudden or severe persistent pain in your lower belly mostly on one side (you could have an ectopic pregnancy) • you develop yellowing of your skin or whites of your eyes especially with fever, tiredness, loss of appetite or dark colored urine Stop use and ask a doctor if • you become pregnant Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDo not use • if you have or ever had breast cancer • if you are already pregnant or think you may be pregnant • together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) • as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex • if you are male
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if • you currently have vaginal bleeding between your periods and you have not already talked to a doctor • you have liver problems • you have or ever had any cancer
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you become pregnant
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Norgestrel 0.075 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NORGESTREL. 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0113-8101-01 | 0113-8101 | L. Perrigo Company | 1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK | March 4, 2024 |
| 0113-8101-03 | 0113-8101 | L. Perrigo Company | 3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK | March 4, 2024 |
| 0113-8101-04 | 0113-8101 | L. Perrigo Company | 4 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK | March 22, 2024 |
| 0113-8101-06 | 0113-8101 | L. Perrigo Company | 6 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK | March 4, 2024 |
| 67296-1938-2 | 67296-1938 | Redpharm Drug | 1 BLISTER PACK in 1 CARTON (67296-1938-2) / 28 TABLET in 1 BLISTER PACK | March 4, 2024 |
| 0113-8101 | 0113-8101 | L. Perrigo Company | — | March 4, 2024 |
| 67296-1938 | 67296-1938 | Redpharm Drug | — | March 4, 2024 |
Sources for 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 |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.