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NDC 43386-0622-30 My Way 1.5 mg/1 Details
My Way 1.5 mg/1
My Way is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is LEVONORGESTREL.
MedlinePlus Drug Summary
Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Levonorgestrel may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 43386-0622-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levonorgestrel
Product Information
NDC | 43386-0622 |
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Product ID | 43386-622_6dce7821-019c-4344-9634-5a51060920d5 |
Associated GPIs | |
GCN Sequence Number | 058193 |
GCN Sequence Number Description | levonorgestrel TABLET 1.5 MG ORAL |
HIC3 | G8A |
HIC3 Description | CONTRACEPTIVES,ORAL |
GCN | 23549 |
HICL Sequence Number | 007318 |
HICL Sequence Number Description | LEVONORGESTREL |
Brand/Generic | Generic |
Proprietary Name | My Way |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Levonorgestrel |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 1.5 |
Active Ingredient Units | mg/1 |
Substance Name | LEVONORGESTREL |
Labeler Name | Lupin Pharmaceuticals,Inc. |
Pharmaceutical Class | Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA202508 |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 43386-0622-30 (43386062230)
NDC Package Code | 43386-622-30 |
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Billing NDC | 43386062230 |
Package | 1 TABLET in 1 CARTON (43386-622-30) |
Marketing Start Date | 2013-02-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ec01077e-ac3c-424a-9edc-0854fe0a2e0d Details
Indications
Warnings
When using this product you may have
Keep out of reach of children
Directions
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
Questions?
For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at www.mywaypill.com
My Way
Emergency Contraceptive
What You Need to Know
What is My Way?
My Way 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 My Way is not.
My Way will not work if you are already pregnant and will not affect an existing pregnancy. My Way will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use My Way?
The sooner you take emergency contraception, the better it works. You should use My Way within 72 hours (3 days) after you have had unprotected sex.
My Way 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
My Way 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 My Way .
My Way is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. My Way 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 My Way 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 My Way?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take My Way, the better it works.
How effective is My Way?
If My Way 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 My Way worked?
You will know My Way 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, My Way 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 My Way?
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
If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
PI6223000201
Rev. 02/2014
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MY WAY
levonorgestrel tablet |
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Labeler - Lupin Pharmaceuticals,Inc. (089153071) |
Registrant - GAVIS Pharmaceuticals, LLC (829838551) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Novel Laboratories, Inc. | 793518643 | analysis(43386-622) , manufacture(43386-622) |