My Way
Levonorgestrel
Lupin Pharmaceuticals,inc.
Human Otc Drug
NDC 43386-622My Way also known as Levonorgestrel is a human otc drug labeled by 'Lupin Pharmaceuticals,inc.'. National Drug Code (NDC) number for My Way is 43386-622. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in My Way drug includes Levonorgestrel - 1.5 mg/1 . The currest status of My Way drug is Active.
Drug Information:
| Drug NDC: | 43386-622 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | My Way |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Levonorgestrel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lupin Pharmaceuticals,inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | LEVONORGESTREL - 1.5 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Feb, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA202508 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Lupin Pharmaceuticals,Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 483325
1426881
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175830
M0447349
N0000175602
N0000175832
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 5W7SIA7YZW
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Progestin [EPC]
Progestin-containing Intrauterine Device [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Inhibit Ovum Fertilization [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Progesterone Congeners [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Inhibit Ovum Fertilization [PE]
Progesterone Congeners [CS]
Progestin [EPC]
Progestin-containing Intrauterine Device [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 43386-622-30 | 1 TABLET in 1 CARTON (43386-622-30) | 15 Feb, 2013 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose emergency contraceptive
Product Elements:
My way levonorgestrel levonorgestrel levonorgestrel silicon dioxide starch, corn lactose monohydrate magnesium stearate talc off-white
Indications and Usage:
Indications use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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
Do Not Use:
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
When Using:
When using this product you may have menstrual changes nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting
Dosage and 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
Package Label Principal Display Panel:
Principal display panel my way (levonorgestrel) tablet , 1.5 mg ndc 43386-622-30 emergency contraceptive reduces chance of pregnancy after unprotected sex. not for regular birth control. contains 1 tablet 1.5mg front panel back panel c:\users\kvyas\desktop\spl\front panel.jpg c:\users\kvyas\desktop\spl\drug facts.jpg
Further Questions:
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 when not to use my way. 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 . how does my way work? 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 20â25°c (68â77°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