Altavera

Levonorgestrel And Ethinyl Estradiol


Xiromed, Llc.
Human Prescription Drug
NDC 70700-116
Altavera also known as Levonorgestrel And Ethinyl Estradiol is a human prescription drug labeled by 'Xiromed, Llc.'. National Drug Code (NDC) number for Altavera is 70700-116. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Altavera drug includes . The currest status of Altavera drug is Active.

Drug Information:

Drug NDC: 70700-116
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: Altavera
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription 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 And Ethinyl Estradiol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Xiromed, Llc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Kit
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:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
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: 01 Sep, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Jun, 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: ANDA079102
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:Xiromed, LLC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:238019
748797
748878
1006065
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.
UNII:
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.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
70700-116-853 CARTON in 1 CARTON (70700-116-85) / 1 BLISTER PACK in 1 CARTON (70700-116-84) / 1 KIT in 1 BLISTER PACK01 Sep, 2022N/ANo
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.

Product Elements:

Altavera levonorgestrel and ethinyl estradiol altavera levonorgestrel and ethinyl estradiol levonorgestrel levonorgestrel ethinyl estradiol ethinyl estradiol anhydrous lactose ferrosoferric oxide ferric oxide red ferric oxide yellow magnesium stearate polyethylene glycol, unspecified polyvinyl alcohol povidone, unspecified talc titanium dioxide peach sz;j4 inert inert anhydrous lactose magnesium stearate polyethylene glycol, unspecified polyvinyl alcohol povidone, unspecified talc titanium dioxide sz;j1 levonorgestrel structure ethinyl estradiol structure figure 1 altavera blister label altavera carton box figure 2 chart

Boxed Warning:

Warning: cigarette smoking and serious cardiovascular events cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (coc) use. this risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. for this reason, cocs, including altavera, are contraindicated in women who are over 35 years of age and smoke [see contraindications and warnings (1)].

Indications and Usage:

Indications and usage altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Description:

Description altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (coc) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). the structural formulas for the active components are: levonorgestrel c 21 h 28 o 2 mw: 312.4 ethinyl estradiol c 20 h 24 o 2 mw: 296.4 ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.

Clinical Pharmacology:

Clinical pharmacology combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

How Supplied:

How supplied/storage and handling altavera tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/30 mcg) are available in packages of 3 compact dispensers, each containing 28 tablets: 21 active tablets: peach, round, unscored, debossed with sz on one side and j4 on the other side. 7 inert tablets: white, round, unscored, debossed with sz on one side and j1 on the other side. 1 individual blister ndc 70700-116-84 3 individual blisters ndc 70700-116-85 store at 20º to 25°c (68° to 77º f) [see usp controlled room temperature]. manufactured by laboratorios leon farma s.a., spain for xiromed, llc., florham park, nj 07932 pi-116-05 rev. 09/2022

Spl Patient Package Insert:

Patient information altavera ® [ all-tuh-vair-u h] (levonorgestrel 0.15 mg and ethinyl estradiol 30 mcg tablets) what is the most important information i should know about altavera? do not use altavera if you smoke cigarettes and are over 35 years old. s moking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. this risk increases with age and the number of cigarettes you smoke. what is altavera? altavera is a birth control pill (oral contraceptive) used by women to prevent pregnancy. how does altavera work for contraception? your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. the better you follow the directions, the less chance you have of getting pregnant. based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use altavera. the following chart shows the chanc
e of getting pregnant for women who use different methods of birth control. each box on the chart contains a list of birth control methods that are similar in effectiveness. the most effective methods are at the top of the chart. the box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. who should not take altavera? do not take altavera if you: • smoke and are over 35 years of age • had blood clots in your arms, legs, lungs, or eyes • had a problem with your blood that makes it clot more than normal • have certain heart valve problems or irregular heart beat • had a stroke • had a heart attack • have high blood pressure that cannot be controlled by medicine • have diabetes with kidney, eye, nerve, or blood vessel damage • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age • had breast cancer or any cancer that is sensitive to female hormones • have liver problems, including liver tumors • have any unexplained vaginal bleeding • are pregnant • take any hepatitis c drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. this may increase levels of the liver enzyme “alanine aminotransferase” (alt) in the blood. if any of these conditions happen while you are taking altavera, stop taking altavera right away and talk to your healthcare provider. use non-hormonal contraception when you stop taking altavera. what should i tell my healthcare provider before taking altavera? tell your healthcare provider if you: • are pregnant or think you may be pregnant • are depressed now or have been depressed in the past • had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) • are breastfeeding or plan to breastfeed. altavera may decrease the amount of breast milk you make. a small amount of the hormones in altavera may pass into your breast milk. talk to your healthcare provider about the best birth control method for you while breastfeeding. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. altavera may affect the way other medicines work, and other medicines may affect how well altavera works. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. how should i take altavera? read the instructions for use at the end of this patient information. what are the possible serious side effects of altavera? • like pregnancy, altavera may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. some other examples of serious blood clots include blood clots in the legs or eyes. serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. serious blood clots are more likely to happen when you: ○ first start taking birth control pills ○ restart the same or different birth control pills after not using them for a month or more call your healthcare provider or go to a hospital emergency room right away if you have: • leg pain that will not go away • sudden change in vision or blindness • sudden shortness of breath • chest pain • a sudden, severe headache unlike your usual headaches • weakness of numbness in your arm or leg • trouble speaking other serious side effects include: • liver problems, including: ○ rare liver tumors ○ jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. call your healthcare provider if you have yellowing of your skin or eyes. • high blood pressure. you should see your healthcare provider for a yearly check of your blood pressure. • gallbladder problems • changes in the sugar and fat (cholesterol and triglycerides) levels in your blood changes in the sugar and fat (cholesterol and triglycerides) levels in your blood • new or worsening headaches, including migraine headaches new or worsening headaches, including migraine headaches • irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking altavera. • depression • possible cancer in your breast and cervix • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. your chance of having angioedema is higher if you have a history of angioedema. • dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking altavera. use sunscreen if you have to be in the sunlight. what are the most common side effects of oral contraceptives? • nausea • weight gain • vomiting • breast tenderness • bleeding between menstrual periods • difficulty wearing contact lenses these are not all the possible side effects of altavera. for more information, ask your healthcare provider or pharmacist. you may report side effects to the fda at 1-800-fda-1088. what else should i know about taking altavera? • if you are scheduled for any lab tests, tell your healthcare provider you are taking altavera. certain blood tests may be affected by altavera. • altavera does not protect against hiv-infection (aids) and other sexually transmitted infections. how should i store altavera? • store altavera at room temperature between 68°f to 77°f (20°c to 25°c). • protect from light. general information about the safe and effective use of altavera. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use altavera for a condition for which it was not prescribed. do not give altavera to other people, even if they have the same symptoms that you have. this patient information leaflet summarizes the most important information about altavera. you can ask your pharmacist or healthcare provider for information about altavera that is written for health professionals. for more information, call 1-844-xiromed (844-947-6633). does hormonal birth control cause cancer? it is not known if hormonal birth control pills causes breast cancer. some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users withlonger duration of use. if you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. there might be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. women who use birth control pills may have a slightly higher chance of getting cervical cancer. however, this may be due to other reasons such as having more sexual partners. what if i want to become pregnant? you may stop taking the pill whenever you wish. consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. what should i know about my period when taking altavera? your periods may be lighter and shorter than usual. some women may miss a period. irregular vaginal bleeding or spotting may happen while you are taking altavera, especially during the first few months of use. this usually is not a serious problem. it is important to continue taking your pills on a regular schedule to prevent a pregnancy. what are the ingredients in altavera? active ingredients : each peach pill contains levonorgestrel and ethinyl estradiol. inactive ingredients: peach pills: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, and titanium dioxide. white pills: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, and titanium dioxide. manufactured by laboratorios leon farma s.a., spain for xiromed, llc., florham park, nj 07932 rev. 09/2022

Package Label Principal Display Panel:

Principal display panel ndc 70700-116-85 altavera ® (levonorgestrel and ethinyl estradiol tablets, usp) 0.15 mg/0.03 mg 28 day regimen 1 unit rx only


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.