Methenamine Mandelate

Edenbridge Pharmaceuticals Llc.
Human Prescription Drug
NDC 42799-106

Methenamine Mandelate is a human prescription drug labeled by 'Edenbridge Pharmaceuticals Llc.'. National Drug Code (NDC) number for Methenamine Mandelate is 42799-106. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Methenamine Mandelate drug includes Methenamine Mandelate - 1000 mg/1 . The currest status of Methenamine Mandelate drug is Active.

Drug Information:

Drug NDC:	42799-106
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:	Methenamine Mandelate
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:	Methenamine Mandelate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Edenbridge Pharmaceuticals Llc.
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:	METHENAMINE MANDELATE - 1000 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:	UNAPPROVED DRUG OTHER
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:	15 Dec, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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.
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:	Edenbridge Pharmaceuticals LLC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	992153 992184
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:	0342799106014 0342799105017
UPC stands for Universal Product Code.
UNII:	695N30CINR
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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
42799-106-01	100 TABLET in 1 BOTTLE (42799-106-01)	15 Dec, 2009	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.

Other medicines with the same generic name

Product Elements:

Methenamine mandelate methenamine mandelate methenamine mandelate methenamine calcium phosphate, dibasic, anhydrous hypromelloses magnesium stearate magnesium aluminum silicate cellulose, microcrystalline silicon dioxide sodium starch glycolate type a potato titanium dioxide fd&c red no. 40 fd&c yellow no. 6 polydextrose maltodextrin medium-chain triglycerides 106 methenamine mandelate methenamine mandelate methenamine mandelate methenamine calcium phosphate, dibasic, anhydrous fd&c blue no. 1 hypromelloses magnesium stearate magnesium aluminum silicate cellulose, microcrystalline silicon dioxide sodium starch glycolate type a potato titanium dioxide polydextrose maltodextrin medium-chain triglycerides 105

Drug Interactions:

Drug interactions formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate, usp should not be administered concurrently with sulfamethizole.

Indications and Usage:

Indications and usage methenamine mandelate, usp is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. when used as recommended, methenamine mandelate, usp is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. pathogens resistant to other antibacterial agents may respond to methenamine mandelate, usp because of the nonspecific effect of formaldehyde formed in an acid urine. prophylactic use rationale: urine is a good culture medium for many urinary pathogens. inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth- Read more...

inhibiting medium. there is a growing body of evidence that long-term administration of methenamine mandelate, usp can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. therapeutic use rationale: methenamine mandelate, usp helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. methenamine mandelate, usp should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. a thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate, usp.

General Precautions:

General precautions dysuria may occur (usually at higher than recommended dosage). this can be controlled by reducing the dosage and the acidification. when urine acidification is contraindicated or unattainable (as with some urea-splitting bacteria), the drug is not recommended.

Dosage and Administration:

Dosage and administration the average adult dose is 4 grams daily given as 1 gram after each meal and at bedtime. children 6 to 12 should receive half the adult dose, and children under 6 years of age should receive 250 mg per 30 lb body weight, four times daily. (see chart) since an acid urine is essential for antibacterial activity, with maximum efficacy occurring at ph 5.5 or below, restriction of alkalinizing foods and medication is thus desirable. if testing of urine ph reveals the need, supplemental acidification should be given. dosages dosage adults pediatric patients tablets tablets 1000mg 1 tablet qid - 500mg 2 tablets qid (ages 6-12) 1 tablet qid

Contraindications:

Contraindications contraindicated in renal insufficiency. methenamine mandelate, usp should not be used in patients who have previously exhibited hypersensitivity to it.

Adverse Reactions:

Adverse reactions an occasional patient may experience gastrointestinal disturbance or a generalized skin rash. microscopic and rarely gross hematuria have been described.

Drug Interactions:

Drug interactions formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate, usp should not be administered concurrently with sulfamethizole.

Use in Pregnancy:

Pregnancy pregnancy category c: animal reproduction studies have not been conducted with methenamine mandelate, usp. it is also not known whether methenamine mandelate, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. methenamine mandelate, usp should be given to a pregnant woman only if clearly needed. since introduction, published reports on the use of methenamine mandelate, usp in pregnant women have not shown an increased risk of fetal abnormalities from use during pregnancy.

Description:

Description: methenamine mandelate, usp, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. methenamine mandelate, usp is available for oral use as film-coated tablets. active ingredients: methenamine mandelate: 500 mg or 0.5 gm. methenamine mandelate: 1000 mg or 1.0 gm. other ingredients: dicalcium phosphate, fd and c blue #1 lake, fd and c red #40 lake, fd and c yellow #6 lake, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate, titanium dioxide, polydextrose, maltodextrin, and medium chain triglycercides.

Clinical Pharmacology:

Clinical pharmacology methenamine mandelate, usp is readily absorbed but remains essentially inactive until it is excreted by the kidney and concentrated in the urine. an acid urine is essential for antibacterial action, with maximum efficacy occurring at ph 5.5 or less. in an acid urine, mandelic acid exerts its antibacterial action and also contributes to the acidification of the urine. mandelic acid is excreted both by glomerular filtration and tubular excretion. the methenamine component, in an acid urine, is hydrolyzed to ammonia and to the bactericidal agent formaldehyde. there is equally effective antibacterial activity against both gram-positive and gram-negative organisms, since the antibacterial action of mandelic acid and formaldehyde is nonspecific. there are reports that methenamine mandelate, usp is ineffective in some infections with proteus vulgaris and urea-splitting strains of pseudomonas aeruginosa and a aerogenes . since urea-splitting strains may raise the ph of th Read more...

e urine, particular attention to supplementary acidification is required. however, results in any single case will depend to a large extent on the underlying pathology and the overall management.

How Supplied:

How supplied methenamine mandelate tablets, usp 500 mg are supplied as: ndc 42799-105-01 bottles of 100 each tablet is blue, film coated, and bears the product code â105â. methenamine mandelate tablets, usp 1000 mg are supplied as: ndc 42799-106-01 bottles of 100 each tablet is pink, film coated, and bears the product code â106â. store at controlled room temperature between 15Â°-30Â°c (59Â°-86Â°f)[see usp]. dispense in a tight, light-resistant container as defined in the usp. manufactured for: edenbridge pharmaceuticals, llc parsippany, nj 07054 877-381-3336 rev. 02/18

Package Label Principal Display Panel:

Package label.principal display panel 100 tablets - 500 mg 100 ct - 1000mg

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.