Levonorgestrel
- Manufacturer
- Novel Laboratories, Inc.
- Effective date
- 2017-09-15
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 20:25:14
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Levonorgestrel 1.5mg
Purpose
Emergency contraceptive
Use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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
Do not use
- if you are already pregnant (because it will not work)
- for regular birth control
- .
Ask a doctor or pharmacist before use if you are
Taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.
When using this product you may have
- menstrual changes
- nausea
- lower stomach (abdominal) pain
- tiredness
- headache
- dizziness
- breast pain
- vomiting
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control center right away.
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.
Other information
- read the instructions, warnings and enclosed product leaflet before use
- this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
- do not use if carton is open or blister seal is broken or missing
- store at 20-25°C (68-77°F)
Inactive ingredients
colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc
Questions?
For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at
www.mywaypill.com
Levonorgestrel Tablet
Emergency Contraceptive
What You Need to Know
What is Levonorgestrel Tablet?
Levonorgestrel Tablet is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.
What Levonorgestrel Tablet is not.
Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
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
When not to use Levonorgestrel Tablet.
Levonorgestrel Tablet should not be used:
- as a regular birth control method, because it's not as effective as regular birth control.
- if you are already pregnant, because it will not work.
- if you are allergic to levonorgestrel or any other ingredients in Levonorgestrel Tablet.
When should I talk to a doctor or pharmacist?
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Levonorgestrel Tablet and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.
How does Levonorgestrel Tablet work?
Levonorgestrel Tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Levonorgestrel Tablet may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).
How can I get the best results from Levonorgestrel Tablet?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet, the better it works.
How effective is Levonorgestrel Tablet?
If Levonorgestrel Tablet is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.
How will I know Levonorgestrel Tablet worked?
You will know Levonorgestrel Tablet has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.
Will I experience any side effects?
- some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
- if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
- when used as directed, Levonorgestrel Tablet is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
- if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.
What if I still have questions about Levonorgestrel Tablet?
If you have questions or need more information, call 1-800-422-8689, or visit our website at www.mywaypill.com
Other Information
Keep out of reach of children:
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Do not use if the blister seal is opened.
Store at room temperature 20–25°C (68–77°F).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate magnesium stearate, and talc
Manufactured by:
Novel Laboratories, Inc
Somerset, NJ 08873
P16223000102 Rev. 09/2017
1-800-422-8689
www.mywaypill.com
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LEVONORGESTREL Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230718 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40032-622-30 | Levonorgestrel | 1 in 1 CARTON | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | 2 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 |
Products#
Every source-derived product name is available through these pages.
- Levonorgestrel
- SILICON DIOXIDE
- STARCH, CORN
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 40032-622 | 40032-622-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LEVONORGESTREL | 5W7SIA7YZW | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TALC | 7SEV7J4R1U | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202508-001 | LEVONORGESTREL | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202508-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2013-02-22 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Levonorgestrel | LEVONORGESTREL | Novel Laboratories, Inc. | ac13a073-a33a-45f7-8483-eecc9190195f | 2017-09-15 | 40032-622-30 40032-622 40032062230 af913ba6-b143-43c5-86fc-a36fd494b29d ac13a073-a33a-45f7-8483-eecc9190195f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
