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Methenamine Mandelate 1000 mg Tablet, Film Coated, 120-count — NDC 62135-0201-12 package photo

Methenamine Mandelate 1000 mg Tablet, Film Coated, 120-count

by Chartwell RX, LLC · 120 TABLET, FILM COATED in 1 BOTTLE (62135-201-12)
NDC 62135-0201-12
🏷️ FDA NDC (as labeled) 62135-201-12 billing pads the product segment with a zero
This package
Contains120-count Cost per ea$2.63 NADAC Per package$315.11 / 120 tablets Pack sizes3 compare ↓
Also comes in: 60 tablets 62135-0201-60 100 tablets 62135-0201-01
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62135-201-12
Product NDC 62135-201
11-digit billing NDC 62135020112
NCPDP billing unit EA — each (per item)
RxCUI 992153, 992184
UNII 695N30CINR
UPC 0362135201609, 0362135200121, 0362135200015, 0362135200602 +2 more
SPL Set ID 69efa19c-64a2-41cb-a298-6e9113e57fd7
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance METHENAMINE MANDELATE
GPI-14 16800020100320
GPI class Methenamine Mandelate
GCN Seq No 009460
GCN 42032
HICL code 004102
Ingredient (HICL) Methenamine Mandelate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name METHENAMINE MAND 1 GM TABLET
FDB brand name Methenamine Mandelate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62135-201-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0201-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other antibacterials class.

Drug family (ATC) Other antibacterials
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerChartwell RX, LLC
Labeler code62135
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio521 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METHENAMINE MAND 1 GM TABLET Ingredient Methenamine Mandelate
📖 What it is MedlinePlus · NLM

Methenamine, an antibiotic, eliminates bacteria that cause urinary tract infections. It usually is used on a long-term basis to treat chronic infections and to prevent recurrence of infections. Antibiotics will not work for colds, flu, or other viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a great question. Methenamine isn't used to clear an active infection — it's used to prevent another one from taking hold. Once your other antibiotic has done that job, meth...
  • Why do I need to take methenamine if my infection is already gone?
  • Yes, it actually does. Methenamine only converts into its active antibacterial form in acidic urine. Foods and medications that make your urine more alkaline — less acidic — can re...
  • Does it matter what I eat or drink while I'm on this medication?
📖 Read our full Methenamine guide →
7
Nutrient depletion considerations

Methenamine Mandelate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Methenamine Mandelate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeOval
ImprintCE;35
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.626 $315.11 / 120 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Mar 2022 Jan 2026 Apr 2026 Aug 2026 $2.706 $1.281
▲ Up 51% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methenamine Mandelate 1000 mg 42799-0106-01 Edenbridge 100 tablets $2.626 — Availability likely —
Methenamine Mandelate 1000 mgthis 62135-0201-12 Chartwell 120 tablets $2.626 — Availability likely —
Methenamine Mandelate 1000 mg 69367-0437-01 Westminster 100 tablets $2.626 — Availability likely —
Methenamine Mandelate 1000 mg 72162-2655-01 Bryant 100 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets62135-0201-60 45 Rx · $5,262
100 tablets62135-0201-01 No Medicaid data
120 tablets this page62135-0201-12 No Medicaid data
Drug total (last 4 qtrs): 45 Rx · 2,869 units · $5,262 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methenamine Mandelate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Methenamine Mandelate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$241K
Claims incl. refills
1.6K
Beneficiaries
1K
Spend / beneficiary
$240.09
Spend / claim
$150.94
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Methenamine Mandelate — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection29
Fatigue21
Asthenia19
Fall19
Diarrhoea18
Malaise13
Nausea13

Age at onset

Adult13
Elderly22

Reporter sex

186 reports
Male · 17%
Female · 83%

Serious outcomes

Hospitalization62
Death15
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 15 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62135-0201-01 100 TABLET, FILM COATED in 1 BOTTLE (62135-201-01) — — 2021-10-01 Active
62135-0201-12 You're viewing this 120 TABLET, FILM COATED in 1 BOTTLE (62135-201-12) $2.63 / ea $315.11 2021-10-01 Active
62135-0201-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-201-60) $2.63 / ea $157.55 2021-10-01 Active

You're viewing the largest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($2.63 NADAC).

Pack size FAQ

What quantity is in NDC 62135-0201-12?
NDC 62135-0201-12 is a 120-count package — 120 tablet, film coated in 1 bottle.
What is the difference between NDC 62135-0201-12 and NDC 62135-0201-60?
Both are Methenamine Mandelate 1000 mg Tablet, Film Coated — the drug itself is identical. NDC 62135-0201-12 is the 120-count package, while NDC 62135-0201-60 is the 60 tablets package.
What NDC number is used to bill for this package of Methenamine Mandelate 1000 mg Tablet, Film Coated?
Bill NDC 62135-0201-12 — the 11-digit billing format is 62135020112. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 62135-201-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62135-0201-12, written without dashes as 62135020112. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62135-0201-12, the first segment (62135) is the labeler code FDA assigned to Chartwell RX, LLC; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Chartwell RX, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (62135-0201-60), 100 tablets (62135-0201-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Chartwell RX, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate 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 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-inhibiting medium.

There is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. Therapeutic Use Rationale : Methenamine mandelate 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 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.

⏱️ Dosage and Administration 50 words ▾

DOSAGE AND ADMINISTRATION The average adult dose is 4 g a day given as one 1000 mg tablet or two 500 mg tablets after each meal and at bedtime. Children 6 to 12 years of age should receive half the adult dose; one 500 mg tablet, 4 times a day.

⛔ Contraindications 29 words ▾

CONTRAINDICATIONS Methenamine mandelate tablets are contraindicated in patients with renal insufficiency, severe hepatic disease, severe dehydration, and in patients who have exhibited hypersensitivity to any components of this product.

⚠️ Warnings 59 words ▾

WARNINGS Methenamine mandelate should be avoided in patients with gout because it may precipitate urate crystals in their urine. A similar situation may arise in patients with a predisposition to the formation of uric acid stones. 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 32 words ▾

ADVERSE REACTIONS Gastrointestinal disturbances (nausea, stomach upset), generalized skin rash, dysuria, painful or difficult urination may occur occasionally with the use of methenamine preparations. Microscopic and rarely, gross hematuria have been described.

🔄 Drug Interactions 45 words ▾

Drug Interactions Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate should not be administered concurrently with sulfamethizole or other sulfonamides. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine.

🔄 Drug / Laboratory Test Interactions 77 words ▾

Drug/Laboratory Test Interactions Formaldehyde interferes with fluorometric procedures for determination of urinary catecholamines and vanillylmandelic acid (VMA), causing erroneously high results. Formaldehyde also causes falsely decreased urine estriol levels by reacting with estriol when acid hydrolysis techniques are used; estriol determinations which use enzymatic hydrolysis are unaffected by formaldehyde. Formaldehyde causes falsely elevated 17-hydroxycorticosteroid levels when the Porter-Silber method is used and falsely decreased 5-hydroxyindoleacetic acid (5HIAA) levels by inhibiting color development when nitrosonaphthol methods are used.

🤰 Pregnancy 65 words ▾

Pregnancy Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with methenamine mandelate. It is also not known whether methenamine mandelate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Since methenamine is known to cross the placental barrier, methenamine mandelate should be given to a pregnant woman only if the potential benefit outweighs the risk.

🧬 Clinical Pharmacology 201 words ▾

CLINICAL PHARMACOLOGY Methenamine mandelate is readily absorbed but remains essentially inactive until it is excreted by the kidneys 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 is hydrolyzed in acid urine to ammonia and to the bactericidal agent formaldehyde. Proportionally less formaldehyde is released as urinary pH approaches 6.0 and insufficient quantities are released above this level for therapeutic response.

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 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 the urine, particular attention to supplementary acidification with agents such as ascorbic acid, and urinary pH monitoring is required.

However, results in any single case will depend to a large extent on the underlying pathology and the overall management.

📦 How Supplied / Storage and Handling 134 words ▾

HOW SUPPLIED Methenamine Mandelate Tablets, USP 500 mg are blue, unscored, oval, film-coated, debossed with "CE 34" on one side and plain on the other side. Supplied in bottles of 60 (NDC 62135-200-60) Supplied in bottles of 100 (NDC 62135-200-01) Supplied in bottles of 120 (NDC 62135-200-12) Methenamine Mandelate Tablets, USP 1000 mg (1 g) are blue, unscored, oval, film-coated, debossed with "CE 35" on one side and plain on the other side. Supplied in bottles of 60 (NDC 62135-201-60) Supplied in bottles of 100 (NDC 62135-201-01) Supplied in bottles of 120 (NDC 62135-201-12) Preserve in well-closed containers Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for: Chartwell RX LLC. Congers, NY 10920 Made in USA L70516 Rev. 09/2021

📋 Description 65 words ▾

DESCRIPTION Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets. Methenamine mandelate tablets contain 500 mg and 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide.

💬 Information for Patients 25 words ▾

Information for Patients To assure an acidic pH, patients should be instructed to restrict or avoid milk products and antacids containing sodium carbonate or bicarbonate.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62135-0200-01 · Chartwell 62135-0205-01 · Chartwell →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.