Spironolactone
Direct Rx
Human Prescription Drug
NDC 72189-329Spironolactone is a human prescription drug labeled by 'Direct Rx'. National Drug Code (NDC) number for Spironolactone is 72189-329. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Spironolactone drug includes Spironolactone - 100 mg/1 . The currest status of Spironolactone drug is Active.
Drug Information:
| Drug NDC: | 72189-329 |
| 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: | Spironolactone |
| 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: | Spironolactone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Direct Rx |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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: | SPIRONOLACTONE - 100 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: | 28 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | ANDA203512 |
| 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: | Direct Rx
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198222
|
| 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. |
| NUI: | N0000175557 N0000011310
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 27O7W4T232
|
| 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 MOA: | Aldosterone Antagonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Aldosterone Antagonist [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: | Aldosterone Antagonist [EPC] Aldosterone Antagonists [MoA]
|
| 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 |
|---|
| 72189-329-90 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-329-90) | 28 Feb, 2022 | 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:
Spironolactone spironolactone dibasic calcium phosphate dihydrate silicon dioxide hypromelloses polyethylene glycol 400 povidone k25 ferric oxide red spironolactone spironolactone lactose monohydrate peppermint oil talc starch, corn magnesium stearate ferric oxide yellow (light peach to peach) af
Indications and Usage:
1.1 heart failure spironolactone tablets are indicated for treatment of nyha class iiiâiv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. spironolactone tablets are usually administered in conjunction with other heart failure therapies. 1.2 hypertension spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and lim
Read more...ited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. 1.3 edema associated with hepatic cirrhosis or nephrotic syndrome spironolactone tablets are indicated for the management of edema in the following settings: cirrhosis of the liver when edema is not responsive to fluid and sodium restriction. nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. because it increases serum potassium, spironolactone tablets may be useful for treating edema when administration of other diuretics has caused hypokalemia. 1.4 primary hyperaldosteronism spironolactone tablets are indicated in the following settings: short-term preoperative treatment of patients with primary hyperaldosteronism. long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery. long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
Dosage and Administration:
Dosage Forms and Strength:
Spironolactone tablets usp 25 mg are light yellow to yellow colored, round, biconvex, film coated tablets with inscription âadâ on one side and plain on the other side having faint odour of peppermint. spironolactone tablets usp 50 mg are light orange to orange colored, oval, biconvex, film coated tablets with inscription âaeâ on one side and breakline on the other side having faint odour of peppermint. spironolactone tablets usp 100 mg are light peach to peach colored, round, biconvex, film coated tablets with inscription âafâ on one side and breakline on the other side having faint odour of peppermint.
Contraindications:
Spironolactone tablets are contraindicated in the patients with: hyperkalemia addison's disease concomitant use of eplerenone
Description:
Spironolactone oral tablets usp, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: chemical structure spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. in addition iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.
How Supplied:
Spironolactone tablets usp 25 mg tablets are light yellow to yellow colored, round, biconvex, film coated tablets with inscription âadâ on one side and plain on the other side having faint odour of peppermint, supplied as: ndc number size 16729-225-01 bottle of 100 with a child-resistant closure 16729-225-16 bottle of 500 16729-225-17 bottle of 1,000 16729-225-19 bottle of 2,500 spironolactone tablets usp 50 mg tablets are light orange to orange colored, oval, biconvex, film coated tablets with inscription âaeâ on one side and breakline on the other side having faint odour of peppermint, supplied as: ndc number size 16729-226-01 bottle of 100 with a child-resistant closure 16729-226-16 bottle of 500 spironolactone tablets usp 100 mg tablets are light peach to peach colored, round, biconvex, film coated tablets with inscription âafâ on one side and breakline on the other side having faint odour of peppermint, supplied as: ndc number size 16729-227-01 bottle
Read more... of 100 with a child-resistant closure 16729-227-16 bottle of 500 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature] protect from light. dispense in tight, light-resistant containers.
Package Label Principal Display Panel:
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