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NDC 62756-0723-60 AfterPlan 1.5 mg/1 Details
AfterPlan 1.5 mg/1
AfterPlan is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by SUN PHARMACEUTICAL INDUSTRIES, 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: 62756-0723-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levonorgestrel
Product Information
NDC | 62756-0723 |
---|---|
Product ID | 62756-723_f86715c5-932d-405d-b81d-286c86409b1e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | AfterPlan |
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 | SUN PHARMACEUTICAL INDUSTRIES, 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 | ANDA202635 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62756-0723-60 (62756072360)
NDC Package Code | 62756-723-60 |
---|---|
Billing NDC | 62756072360 |
Package | 1 BLISTER PACK in 1 CARTON (62756-723-60) / 1 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2017-05-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a Details
Use
Warnings
Sexually transmitted diseases (STDs) alert
This product does not protect against HIV/AIDS or other STDs.
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.
Directions
Other information
- 1.
- read the instructions, warnings, and enclosed product leaflet before use
- 2.
- 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).
- 3.
- do not use if carton is open or tear strip is removed or blister seal is broken or missing
- 4.
- store at 20° to 25°C (68° to 77°F)
Inactive ingredients
LEVONORGESTREL TABLET, 1.5 mg
Emergency Contraceptive
One Tablet. One Step.
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:
- 1.
- your regular birth control was used incorrectly or failed
- 2.
- you did not use any birth control method
When not to use levonorgestrel tablet.
Levonorgestrel tablet should not be used:
- 1.
- as a regular birth control method, because it's not as effective as regular birth control.
- 2.
- if you are already pregnant, because it will not work.
- 3.
- 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?
- 1.
- 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.
- 2.
- if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
- 3.
- 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.
- 4.
- 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 our toll-free number, 1-800-818-4555.
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° to 25° C (68° to 77° F).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, talc, corn starch, lactose monohydrate
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:
Sun Pharmaceutical Industries Limited
Halol-Baroda Highway,
Halol-389 350, Gujarat, India.
March 2018
5182666
PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
†Compare To
the active ingredient of
Plan B One-Step®
NDC 62756-723-60
See New Warning
AfterPlan™
Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive
- 1.
- The sooner you take it, the more effective it will be
- 2.
- Take as soon as possible within 72 hours (3 days)
after unprotected sex - 3.
- Will not harm an existing pregnancy
- 4.
- Reduces the chance of pregnancy after unprotected sex
- 5.
- Not for regular birth control
Contains 1 Tablet 1.5 mg
One Step.
INGREDIENTS AND APPEARANCE
AFTERPLAN
levonorgestrel tablet |
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Labeler - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Sun Pharmaceutical Industries Limited | 725959238 | ANALYSIS(62756-723) , MANUFACTURE(62756-723) |