Norethindrone


Lupin Pharmaceuticals, Inc.
Human Prescription Drug
NDC 68180-876
Norethindrone is a human prescription drug labeled by 'Lupin Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Norethindrone is 68180-876. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Norethindrone drug includes Norethindrone - .35 mg/1 . The currest status of Norethindrone drug is Active.

Drug Information:

Drug NDC: 68180-876
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: Norethindrone
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: 11 Nov, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 Dec, 2025
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: ANDA091325
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
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:0368180876717
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
68180-876-733 BLISTER PACK in 1 CARTON (68180-876-73) / 28 TABLET in 1 BLISTER PACK (68180-876-71)11 Nov, 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:

Norethindrone norethindrone norethindrone norethindrone anhydrous lactose d&c yellow no. 10 fd&c yellow no. 6 povidone k30 starch, corn lactose monohydrate magnesium stearate yellow round flat lu;j22

Boxed Warning:

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke.

Warning: cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke.

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 0.5%. however, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. the following table lists the pregnancy rates for users of all major methods of contraception. table 2. 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. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year 3 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 reason. 2 among couples who initi
ate 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. 3 among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 the percentage of women becoming pregnant noted 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 one year. this estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one 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 cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 with spermicidal cream or jelly. 8 without spermicides. 9 the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the food and drug administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: ovral ® (1 dose is 2 white pills), alesse ® (1 dose is 5 pink pills), nordette ® or levlen ® (1 dose is 4 yellow pills). 1 0 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. method typical use 1 perfect use 2 ( 1 ) ( 2 ) ( 3 ) ( 4 ) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal 6 2 post-ovulation 1 cap 7 parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm 7 20 6 56 withdrawal 19 4 condom 8 female (reality) 21 5 56 male 14 3 61 pill 5 71 progestin only 0.5 combined 0.1 iuds progesterone t 2.0 1.5 81 copper t380a 0.8 0.6 78 lng 20 0.1 0.1 81 depo-provera ® 0.3 0.3 70 levonorgestrel implants (norplant ® ) 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 emergency contraceptive pills : treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 lactational amenorrhea method : lam is a highly effective, temporary method of contraception. 1 0 source : trussell, j, contraceptive efficacy. in: hatcher ra, trussell j, stewart f, cates w, stewart gk, kowal d, guest f, contraceptive technology: seventeenth revised edition. new york, ny: irvington publishers, 1998.

Warnings:

Warnings cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke. norethindrone tablets do 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. the health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. the relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (pop) use to an increased risk of heart attack or stroke. the physician 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 extrauterine. 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. health providers 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 epidemiologic 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 increase the risk. women with breast cancer should not use oral contraceptives because the role of female hormone 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 from britain and the u.s. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. however, these cancers are rare. 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, norethindrone tablets 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 patient labeling for detailed instructions.

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 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.

Overdosage:

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

Description:

Description each yellow norethindrone tablet usp provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include d&c yellow no. 10, fd&c yellow no. 6, lactose anhydrous, lactose monohydrate, corn starch, povidone and magnesium stearate. the chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. the structural formula follows: norethindrone therapeutic class = oral contraceptive

Clinical Pharmacology:

Clinical pharmacology 1. mode of action norethindrone tablets progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle lh and fsh peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. 2. pharmacokinetics absorption norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after norethindrone tablet administration (see table 1). norethindrone appears to be completely absorbed following oral administration; however, it is subject to first pass metabolism resulting in an absolute bioavailability of approximately 65%. figure 1 : mean ± sd norethindrone plasma concentrations following norethindrone tablets administration. peak plasma concentrations occur approximately 1 hour after administration (mean t max 1.2 hours). the mean (sd) c max was 4816.8 (1532.6) pg/ml and
generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. the mean (sd) c avg was 885 (250) pg/ml, however, the mean concentration at 24 hrs was 130 (47) pg/ml. table 1 provides summary statistics of the pharmacokinetic parameters associated with single dose norethindrone tablets administration. table 1: mean ± sd pharmacokinetic parameters following single dose administration of norethindrone tablets in 12 healthy female subjects under fasting conditions pharmacokinetic parameter norethindrone 0 . 35 mg t m a x (hr) 1.2 ± 0.5 c m a x (pg/ml) 4817 ± 1533 auc ( 0 - 4 8 ) (pg.h/ml) 21233 ± 6002 t 1 / 2 (h) 7.7 ± 0.5 the food effect on the rate and extent of norethindrone absorption after norethindrone tablet administration has not been evaluated. distribution following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (shbg) and 61% bound to albumin. volume of distribution of norethindrone is approximately 4 l/kg. metabolism norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20-40% of a dose is excreted in urine and feces, respectively. the majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites. excretion plasma clearance rate for norethindrone has been estimated to be approximately 600 l/day. norethindrone is excreted in both urine and feces, primarily as metabolites. the mean terminal elimination half-life of norethindrone following single dose administration of norethindrone tablet is approximately 8 hours. figure 1 mean sd norethindrone plasma concentrations following uforla administration

How Supplied:

How supplied norethindrone tablets usp containing 0.35 mg of norethindrone, are yellow coloured, round flat face beveled edge tablets debossed with "lu" on one side and "j22" on the other side. nnorethindrone tablets usp are available in a blister (ndc 68180-876-71) containing 28 tablets. three such blisters are packaged in a carton (ndc 68180-876-73). storage store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Principal display panel norethindrone tablets usp 0.35 mg rx only ndc 68180-876-71 blister label: 28 tablets 28 day regimen www.birthcontrolhealth.com norethindrone tablets usp 0.35 mg rx only ndc 68180-876-73 carton label: 3 blisters, 28 tablets each 28 day regimen www.birthcontrolhealth.com norethindrone tablets usp 0.35 mg rx only ndc 68180-876-71 blister label: 28 tablets 28 day regimen norethindrone tablets usp 0.35 mg rx only ndc 68180-876-73 carton label: 3 blisters, 28 tablets each 28 day regimen


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