Athentia Next
Levonorgestrel
Aurohealth Llc
Human Otc Drug
NDC 58602-721Athentia Next also known as Levonorgestrel is a human otc drug labeled by 'Aurohealth Llc'. National Drug Code (NDC) number for Athentia Next is 58602-721. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Athentia Next drug includes Levonorgestrel - 1.5 mg/1 . The currest status of Athentia Next drug is Active.
Drug Information:
| Drug NDC: | 58602-721 |
| 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: | Athentia Next |
| 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: | Aurohealth Llc |
| 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: | 08 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | ANDA206867 |
| 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: | Aurohealth LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 483325
|
| 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 |
|---|
| 58602-721-57 | 1 BLISTER PACK in 1 CARTON (58602-721-57) / 1 TABLET in 1 BLISTER PACK | 08 Dec, 2015 | 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:
Athentia next levonorgestrel levonorgestrel levonorgestrel silicon dioxide starch, corn lactose monohydrate magnesium stearate starch, potato talc white to off-white s;11
Indications and Usage:
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.
Information for Patients:
Patient information athentia next⢠(levonorgestrel tablet 1.5 mg ) emergency contraceptive one tablet. one step. what you need to know what is athentia next� athentia next⢠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 athentia next⢠is not. athentia next⢠will not work if you are already pregnant and will not affect an existing pregnancy. athentia next⢠will not protect you from hiv infection (the virus that causes aids) and other sexually transmitted diseases (stds). when should i use athentia next� the sooner you take emergency contraception, the better it works. you should use athentia next⢠within 72 hours (3 days) after you have had unprotected sex . athentia next⢠is a backup or emergency method of birth control you can use when: your regular birth control was used incorrectly
Read more...or failed you did not use any birth control method when not to use athentia nextâ¢. athentia next⢠should not be used: as a regular birth control method, because itâs 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 athentia nextâ¢. 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 athentia next⢠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 athentia next⢠work? athentia next⢠is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. athentia next⢠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 athentia next⢠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 athentia nextâ¢? you have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. the sooner you take athentia nextâ¢, the better it works . how effective is athentia nextâ¢? if athentia next⢠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 athentia next⢠worked? you will know athentia next⢠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, athentia next⢠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 athentia nextâ¢? if you have questions or need more information, call our toll-free number aurohealth llc at 1-855-274-4122. 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, corn starch, lactose monohydrate, magnesium stearate, potato starch, 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. distributed by: aurohealth llc 2572 brunswick pike lawrenceville, nj 08648 manufactured by: aurobindo pharma limited hyderabad-500 038, india revised: 08/2017
Package Label Principal Display Panel:
Package label-principal display panel -1.5 mg (1 tablet carton label) ndc 58602-721-57 athentia next⢠(levonorgestrel tablet 1.5 mg) emergency contraceptive reduces chance of pregnancy after unprotected sex. not for regular birth control. one tablet. one step. the sooner you take it, the more effective it will be take as soon as possible within 72 hours (3 days) after unprotected sex will not harm an existing pregnancy 1 tablet levonorgestrel 1.5 mg aurohealth package label-principal display panel - 1.5 mg (1 tablet carton label)
Further Questions:
Questions? call 1-855-274-4122 distributed by: aurohealth llc 2572 brunswick pike lawrenceville, nj 08648 made in india code: ts/drugs/22/2009 revised: 08/2017