Norethindrone Acetate
Norethindrone
Avkare
Human Prescription Drug
NDC 42291-650Norethindrone Acetate also known as Norethindrone is a human prescription drug labeled by 'Avkare'. National Drug Code (NDC) number for Norethindrone Acetate is 42291-650. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Norethindrone Acetate drug includes Norethindrone Acetate - 5 mg/1 . The currest status of Norethindrone Acetate drug is Active.
Drug Information:
| Drug NDC: | 42291-650 |
| 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 Acetate |
| 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: | Avkare |
| 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 ACETATE - 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: | 18 Jun, 2013 |
| 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: | ANDA200275 |
| 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: | AvKARE
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1000405
|
| 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. |
| UNII: | 9S44LIC7OJ
|
| 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: | Progesterone Congeners [CS]
Progestin [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 |
|---|
| 42291-650-90 | 90 TABLET in 1 BOTTLE (42291-650-90) | 18 Jun, 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. |
Product Elements:
Norethindrone acetate norethindrone lactose magnesium stearate cellulose, microcrystalline norethindrone acetate norethindrone off-white an;475
Indications and Usage:
Indications and usage norethindrone acetate tablets, usp is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets, usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Warnings:
Warnings 1. cardiovascular disorders patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of vte, obesity, and systemic lupus erythematosus) should be managed appropriately. 2. visual abnormalities discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. if examination reveals papilledema or retinal vascular lesions, medication should be discontinued.
Dosage and Administration:
Dosage and administration therapy with norethindrone acetate tablets, usp must be adapted to the specific indications and therapeutic response of the individual patient. secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg norethindrone acetate, usp may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. progestin withdrawal bleeding usually occurs within three to seven days after discontinuing norethindrone acetate, usp therapy. patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate tablets, usp. endometriosis: initial daily dosage of 5 mg norethindrone acetate, usp for two weeks. dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate, usp is reached. therapy ma
Read more...y be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Contraindications:
Contraindications known or suspected pregnancy. there is no indication for norethindrone acetate, usp in pregnancy. (see precautions .) undiagnosed vaginal bleeding known, suspected or history of cancer of the breast active deep vein thrombosis, pulmonary embolism or history of these conditions active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) impaired liver function or liver disease as a diagnostic test for pregnancy hypersensitivity to any of the drug components
Adverse Reactions:
Adverse reactions see warnings and precautions . the following adverse reactions have been observed in women taking progestins: breakthrough bleeding spotting change in menstrual flow amenorrhea edema changes in weight (decreases, increases) changes in the cervical squamo-columnar junction and cervical secretions cholestatic jaundice rash (allergic) with and without pruritus melasma or chloasma clinical depression acne breast enlargement/tenderness headache/migraine urticaria abnormalities of liver tests (i.e., ast, alt, bilirubin) decreased hdl cholesterol and increased ldl/hdl ratio mood swings nausea insomnia anaphylactic/anaphylactoid reactions thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) optic neuritis (which may lead to partial or complete loss of vision) to report suspected adverse reactions contact avkare, inc. at 1-855-361-3993; email drugsafety@avkare.com; or fda at 1-800-f
Read more...da-1088 or www.fda.gov/medwatch.
Description:
Description norethindrone acetate tablets, usp - 5 mg oral tablets. norethindrone acetate, usp (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone, usp. it is a white, or creamy white, crystalline powder. norethindrone acetate tablets, usp contain the following inactive ingredients: lactose, magnesium stearate, and microcrystalline cellulose. cd236b39-figure-01
Clinical Pharmacology:
Clinical pharmacology norethindrone acetate induces secretory changes in an estrogen-primed endometrium. on a weight basis, it is twice as potent as norethindrone. pharmacokinetics absorption norethindrone acetate is completely and rapidly deacetylated to norethindrone (net) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. norethindrone acetate is rapidly absorbed from norethindrone acetate tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. the pharmacokinetic parameters of norethindrone following single oral administration of norethindrone acetate in 29 healthy female volunteers are summarized in table 1. table 1.pharmacokinetic parameters after a single dose of norethindrone acetate in healthy women norethindrone acetate (n=29) arithmetic mean ± sd norethindrone (net) auc = area under the curve, c max = maximum plasma concentration, t
Read more... max = time at maximum plasma concentration, t 1/2 = half-life, sd = standard deviation auc (0-inf) (ng/ml*h) 166.90 ± 56.28 c max (ng/ml) 26.19 ± 6.19 t max (h) 1.83 ± 0.58 t 1/2 (h) 8.51 ± 2.19 figure 1. mean plasma concentration profile after a single dose of 5 mg administered to 29 healthy female volunteers under fasting conditions effect of food the effect of food administration on the pharmacokinetics of norethindrone acetate has not been studied. distribution norethindrone is 36% bound to sex hormone-binding globulin (shbg) and 61% bound to albumin. volume of distribution of norethindrone is about 4 l/kg. metabolism norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. the majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites. excretion plasma clearance value for norethindrone is approximately 0.4 l/hr/kg. norethindrone is excreted in both urine and feces, primarily as metabolites. the mean terminal elimination half-life of norethindrone following a single dose administration of norethindrone acetate is approximately 9 hours. special populations geriatrics the effect of age on the pharmacokinetics of norethindrone after norethindrone acetate administration has not been evaluated. race the effect of race on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. renal insufficiency the effect of renal disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. in premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma norethindrone concentration was unchanged compared to concentrations in premenopausal women with normal renal function. hepatic insufficiency the effect of hepatic disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. however, norethindrone acetate is contraindicated in markedly impaired liver function or liver disease. drug interactions no pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate have been conducted. cd236b39-figure-02
How Supplied:
How supplied norethindrone acetate tablets, usp, 5 mg, are supplied as white to off-white oval, biconvex tablets debossed with âanâ bisect â475â on one side and plain on the other side. they are available as follows: bottles of 90: ndc 42291-650-90 store at 20º to 25ºc (68º to 77ºf) [see usp controlled room temperature].
Package Label Principal Display Panel:
Package label.principal display panel avkare ® ndc 42291-650-90 norethindrone acetate tablets, usp 5 mg orally active progestin 90 tablets rx only pharmacist: dispense the accompanying patient information leaflet to each patient. each tablet contains 5 mg norethindrone acetate, usp. usual dosage: see package insert for full prescribing information. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). keep this and all medications out of the reach of children. manufactured for: avkare, inc. pulaski, tn 38478 mfg. rev. 09-2015-00 av rev. 05/17 (p) label 1