Methenamine Hippurate
Avpak
Human Prescription Drug
NDC 50268-549Methenamine Hippurate is a human prescription drug labeled by 'Avpak'. National Drug Code (NDC) number for Methenamine Hippurate is 50268-549. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Methenamine Hippurate drug includes Methenamine Hippurate - 1000 mg/1 . The currest status of Methenamine Hippurate drug is Active.
Drug Information:
| Drug NDC: | 50268-549 |
| 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 Hippurate |
| 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 Hippurate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Avpak |
| 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 HIPPURATE - 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: | 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: | 02 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | ANDA212172 |
| 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: | AvPAK
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992150
|
| 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: | M329791L57
|
| 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 |
|---|
| 50268-549-15 | 50 BLISTER PACK in 1 CARTON (50268-549-15) / 1 TABLET in 1 BLISTER PACK (50268-549-11) | 02 Dec, 2020 | 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:
Methenamine hippurate methenamine hippurate silicon dioxide povidone k90 magnesium stearate methenamine hippurate methenamine white to off-white h;1
Indications and Usage:
Indications methenamine hippurate tablets usp are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Warnings:
Warnings large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
Dosage and Administration:
Dosage and administration 1 tablet (1 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. since the antibacterial activity of methenamine hippurate is greater in acid urine, restriction of alkalinizing foods and medications is desirable. if necessary, as indicated by urinary ph and clinical response, supplemental acidification of the urine should be instituted. the efficacy of therapy should be monitored by repeated urine cultures.
Contraindications:
Contraindications methenamine hippurate tablets usp are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.
Adverse Reactions:
Adverse reactions minor adverse reactions have been reported in less than 3.5% of patients treated. these reactions have included nausea, upset stomach, dysuria, and rash. to report suspected adverse reactions, contact avkare at 1-855-361-3993 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Geriatric Use:
Geriatric use clinical studies of methenamine hippurate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. methenamine hippurate is contraindicated in patients with renal insufficiency and severe hepatic insufficiency (s ee contraindications ). information for patients patients should be counseled that antibacterial drugs including methenamine hippurate should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when methenamine hippurate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by methenamine hippurate or other antibacterial drugs in the future.
Description:
Description each white to off-white capsule-shaped tablet contains 1 g methenamine hippurate usp which is the hippuric acid salt of methenamine (hexamethylene tetramine). the tablet also contains inactive ingredients colloidal silicon dioxide, magnesium stearate and povidone k90.
How Supplied:
How supplied white to off white colored, capsule shaped, biconvex tablets, debossed with "h" and "1" on either side of breakline on one side and other side plain with approximate length 20.00 mm, width 8.00 mm and thickness 7.40 mm. ndc 50268-549-15 (10 tablet per card, 5 cards per carton). dispensed in unit dose packaging. for institutional use only. store at 20°c to 25°c (68°f to 77°f); excursions permitted between 15°c and 30°c (59°f and 86°f) [see usp controlled room temperature]. manufactured for: avkare pulaski, tn 38478 mfg. rev. 07/18 av 11/20 (p) avpak
Package Label Principal Display Panel:
Package label.principal display panel 1g