Jencycla

Norethindrone


Lupin Pharmaceuticals, Inc.
Human Prescription Drug
NDC 68180-877
Jencycla also known as Norethindrone is a human prescription drug labeled by 'Lupin Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Jencycla is 68180-877. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Jencycla drug includes Norethindrone - .35 mg/1 . The currest status of Jencycla drug is Active.

Drug Information:

Drug NDC: 68180-877
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: Jencycla
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: Norethindrone
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:NORETHINDRONE - .35 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: 07 Jul, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jan, 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: ANDA091323
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:198042
748961
1422896
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.
UPC:0368180877714
UPC stands for Universal Product Code.
NUI:M0447349
N0000175602
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:T18F433X4S
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]
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 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:Progesterone Congeners [CS]
Progestin [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
68180-877-731 BLISTER PACK in 1 CARTON (68180-877-73) / 28 TABLET in 1 BLISTER PACK (68180-877-71)07 Jul, 2020N/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:

Jencycla norethindrone norethindrone norethindrone anhydrous lactose d&c yellow no. 10 fd&c blue no. 1 sodium starch glycolate type a potato povidone magnesium stearate green round lu;o23

Indications and Usage:

Indications and usage 1. indications progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. efficacy if used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. however, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. table 1 lists the pregnancy rates for users of all major methods of contraception. table 1: percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. united states. emergency contraception: emergency contraceptive pills or insertion of a copper intrauterine contraceptive after unprotected intercourse substantially reduces the risk of pregnancy.9 (see chapter 6.). lactational amenorrhea method: lam is a highly effective, temporary method of contraception.10 (see chapter 18.) source: trussell j. contraceptive efficacy. in
hatcher ra, trussell j, nelson al, cates w, kowal d, policar m. contraceptive techology: twentieth revised edition. new york ny: ardent media, 2011. notes: 1 among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and depo-provera are taken from the 1995 national survey of family growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods. 2 among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. see the text for the derivation of the estimate for each method. 3 among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4 the percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within 1 year. this estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 foams, creams, gels, vaginal suppositories, and vaginal film. 6 the ovulation and two day methods are based on evaluation of cervical mucus. the standard days method avoids intercourse on cycle days 8 through 19. the symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day. 7 without spermicides. 8 with spermicidal cream or jelly. 9 ella, plan b one-step and next choice are the only dedicated products specifically marketed for emergency contraception. the label for plan b one-step (one dose is 1 white pill) says to take the pill within 72 hours after unprotected intercourse. research has shown that all of the brands listed here are effective when used within 120 hours after unprotected sex. the label for next choice (one dose is 1 peach pill) says to take 1 pill within 72 hours after unprotected intercourse and another pill 12 hours later. research has shown that both pills can be taken at the same time with no decrease in efficacy or increase in side effects and that they are effective when used within 120 hours after unprotected sex. the fda has in addition declared the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: ogestrel (1 dose is 2 white pills), nordette (1 dose is 4 light-orange pills), cryselle, levora, low-ogestrel, lo/ovral, or quasence (1 dose is 4 white pills), jolessa, portia, seasonale or trivora (1 dose is 4 pink pills), seasonique (1 dose is 4 light-blue-green pills), enpresse (one dose is 4 orange pills), lessina (1 dose is 5 pink pills), aviane or loseasonique (one dose is 5 orange pills), lutera or sronyx (one dose is 5 white pills), and lybrel (one dose is 6 yellow pills). 10 however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year 3 method typical use 1 perfect use 2 (1) (2) (3) (4) no method 85 85 spermicides 5 28 18 42 fertility,awareness-based methods 24 47 standard days method twoday method 5 4 ovulation method 3 symptothermal method 6 0.4 withdrawal 22 4 46 sponge 36 parous women 24 20 nulliparous women 12 9 condom female (fc) 21 5 41 male 18 2 43 diaphragm 12 6 57 combined pill and progestin only pill 9 0.3 67 norelgestromin and ethinyl estradiol patch 9 0.3 67 nuvaring 9 0.3 67 depo-provera 6 0.2 56 intrauterine contraceptives paragard (copper t) mirena(lng) 0.8 0.2 0.6 0.2 78 80 implanon 0.05 0.05 84 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 jencycla tablets have not been studied for and are not indicated for use in emergency contraception.

Warnings:

Warnings cigarette smoking increases the risk of serious cardiovascular disease. women who use oral contraceptives should be strongly advised not to smoke. jencycla does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (cocs). the healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. the relationship between progestin-only oral contraceptives and these risks is not fully defined. the healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. ectopic pregnancy the incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extraut
erine. although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. 2. delayed follicular atresia/ovarian cysts if follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. generally these enlarged follicles disappear spontaneously. often they are asymptomatic; in some cases they are associated with mild abdominal pain. rarely they may twist or rupture, requiring surgical intervention. 3. irregular genital bleeding irregular menstrual patterns are common among women using progestin-only oral contraceptives. if genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. if prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. 4. carcinoma of the breast and reproductive organs some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. these studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of pops similarly increases the risk. a meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. this increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. there was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use. women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined. some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. however, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. there is insufficient data to determine whether the use of pops increases the risk of developing cervical intraepithelial neoplasia. 5. hepatic neoplasia benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the united states. rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. however, these cancers are rare in the u.s. there is insufficient data to determine whether pops increase the risk of developing hepatic neoplasia.

Dosage and Administration:

Dosage and administration to achieve maximum contraceptive effectiveness, jencycla must be taken exactly as directed. one tablet is taken every day, at the same time. administration is continuous, with no interruption between pill packs. see detailed patient labeling for detailed instruction.

Contraindications:

Contraindications progestin-only oral contraceptives (pops) should not be used by women who currently have the following conditions: known or suspected pregnancy known or suspected carcinoma of the breast undiagnosed abnormal genital bleeding hypersensitivity to any component of this product benign or malignant liver tumors acute liver disease

Adverse Reactions:

Adverse reactions adverse reactions reported with the use of pops include: menstrual irregularity is the most frequently reported side effect. frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. androgenic side effects such as acne, hirsutism, and weight gain occur rarely. the following adverse reactions were also reported in clinical trials or during post-marketing experience: gastrointestinal disorders: vomiting, abdominal pain; general disorders and administration site conditions: fatigue, edema; psychiatric disorders: depression, nervousness; musculoskeletal and connective tissue disorders: pain in extremity; reproductive system and breast disorders: genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is st
opped; immune system disorders: anaphylactic/anaphylactoid reaction, hypersensitivity ; hepatobiliary disorders: hepatitis, jaundice cholestatic; skin and subcutaneous tissue disorders: alopecia, rash, rash pruritic.

Overdosage:

Overdosage there have been no reports of serious ill effects from overdosage, including ingestion by children.

Description:

Description jencycla™ tablets each tablet contains 0.35 mg norethindrone. inactive ingredients include d&c yellow no. 10, fd&c blue no. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate. the chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. it has a molecular formula of c 20 h 26 o 2 and a molecular weight of 298.4. it has the following structural formula: jencycla meets usp dissolution test 2. norethindrone

Description jencycla™ tablets each tablet contains 0.35 mg norethindrone. inactive ingredients include d&c yellow no. 10, fd&c blue no. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate. the chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. it has a molecular formula of c 20 h 26 o 2 and a molecular weight of 298.4. it has the following structural formula: jencycla meets usp dissolution test 2.

Clinical Pharmacology:

Clinical pharmacology 1. mode of action jencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle lh and fsh peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. 2. pharmacokinetics serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. by 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. there are large variations in serum levels among individual users. progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

How Supplied:

How supplied jencycla tablets containing 0.35 mg of norethindrone, green colored, round, flat face, beveled edge tablets, debossed with "o23" on one side and "lu" on the other side. jencycla tablets are available in a blister (ndc 68180-877-71) containing 28 tablets. such three blisters are packaged in a carton (ndc 68180-877-73). storage : store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. keep out of reach of children.

Information for Patients:

Information for patients 1. see " detailed patient labeling " for detailed information. 2. counseling issues the following points should be discussed with prospective users before prescribing progestin-only oral contraceptives: the necessity of taking pills at the same time every day, including throughout all bleeding episodes. the need to use a backup method such as condom and spermicide for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late. the potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities. the need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain. the importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting stds/hiv.

Package Label Principal Display Panel:

Package label.principal display panel jencycla™ (norethindrone tablets usp) 0.35 mg carton pack: ndc: 68180-877-73 3 blisters of 28 tablets each jencycla™ (norethindrone tablets usp) 0.35 mg blister pack: ndc: 68180-877-71 1 blister of 28 tablets jencycla (norethindrone tablets usp) 0.35 mg 28 day regimen carton pack: ndc: 68180-877-13 3 wallets of 28 tablets each jencycla (norethindrone tablets usp) 0.35 mg 28 day regimen wallet pack: ndc: 68180-877-11 1 wallet of 28 tablets


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