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Methenamine Hippurate 1 g Tablet, 100-count — NDC 70685-0050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Methenamine Hippurate 1 g Tablet, 100-count — NDC 70685-050-01 (Billing 70685-0050-01)

by Esjay Pharma LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Methenamine Hippurate 1 g Tablet from Esjay Pharma LLC, no longer marketed (first marketed Jan 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 70685-0050-01
🏷️ FDA NDC (as labeled) 70685-050-01 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 70685-050-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70685 labeler · 050 product · 01 package
Package marketed since
Jan 16, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7068505001 1
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70685-050-01
Product NDC 70685-050
11-digit billing NDC 70685005001
RxCUI 992150
UNII M329791L57
Application # NDA017681
SPL Set ID 056b14e1-4e31-4549-880c-4f32cee3516f
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-01-16
Route ORAL
Dosage form TABLET
Substance METHENAMINE HIPPURATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 992150
Why two NDCs? The FDA registers this code as 70685-050-01 — 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 → 70685-0050-01. 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.

Clinical

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

🧪 Full Methenamine Hippurate 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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $0.5951 $59.51 / 100 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70685-0050-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2025-01-16 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methenamine Hippurate 1000 mg 42571-0332-01 Micro 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 47781-0577-01 Alvogen 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1000 mg 50268-0549-15 AvPAK 50 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 50742-0142-01 Ingenus 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 59746-0797-01 Jubilant 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1000 mg 60687-0694-21 American 30 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 65862-0782-01 Aurobindo 100 tablets $0.313 AB Availability likely —
Methenamine hippurate 1 g 72578-0175-01 Viona 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 72603-0816-01 NorthStar 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 70954-0959-10 ANI 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 51407-0880-01 Golden 100 tablets — AB FDA listed —
Methenamine Hippurate 1 gthis 70685-0050-01 Esjay 100 tablets — AB Discontinued —
Methenamine hippurate 1 g 70771-1919-01 Zydus 100 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

🧪 Avoiding an ingredient? See Methenamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.

4 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.

Manufacturer & labeler

LabelerEsjay Pharma LLC
Application holderESJAY PHARMA LLC
FDA applicationNDA017681 (NDA)
Labeler code70685
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Esjay Pharma LLC labeler code 70685

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.

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 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 118 words ▾

INDICATIONS Methenamine hippurate tablets 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 tablets and other antibacterial drugs, methenamine hippurate tablets 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.

⏱️ Dosage and Administration 94 words ▾

DOSAGE AND ADMINISTRATION 1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1.0 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets 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 40 words ▾

CONTRAINDICATIONS Methenamine hippurate tablets 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.

⚠️ Warnings 25 words ▾

WARNING Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

🤒 Adverse Reactions 42 words ▾

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 Esjay Pharma LLC at 1-800-239-9339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📦 How Supplied / Storage and Handling 72 words ▾

HOW SUPPLIED 1 gram - Yellow, capsule shaped tablet debossed with E50 on one side and scored on other side, available in bottles of 100 (NDC 70685-050-01). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure. Manufactured for: Esjay Pharma LLC East Windsor, NJ 08520, USA. Made in India Rev. 10/2025

📋 Description 213 words ▾

DESCRIPTION Each yellow, 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: FD&C Yellow No. 5 (tartrazine, see PRECAUTIONS ), magnesium stearate, povidone, and saccharin sodium.

ACTIONS Microbiology: Methenamine hippurate tablets have antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli , enterococci and staphylococci.

Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited. Human Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of methenamine hippurate tablets, antibacterial activity is demonstrable in the urine.

Urine has continuous antibacterial activity when methenamine hippurate tablets are administered at the recommended dosage schedule of 1-gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration.

This action may be important in older patients or in those with some degree of renal impairment.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Prescribing methenamine hippurate tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 1. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas .

2. In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking methenamine hippurate tablets. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.

3. Use in Pregnancy: In early pregnancy the safe use of methenamine hippurate tablets is not established. In the last trimester, safety is suggested, but not definitely proved.

No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. Methenamine hippurate tablets taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde.

Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem. 4. This product contains FD&C Yellow No.

5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Geriatric Use Clinical studies of methenamine hippurate tablets 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 tablets are contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS ) . Information for Patients Patients should be counseled that antibacterial drugs including methenamine hippurate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When methenamine hippurate tablets are 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 tablets or other antibacterial drugs in the future.

📄 Package Label / Principal Display Panel 8 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label (100s) label-100s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for Methenamine Hippurate — the program that covers self-administered drugs. 7 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 Hippurate. 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
$18.08M
Claims incl. refills
301K
Beneficiaries
166.6K
Spend / beneficiary
$108.53
Spend / claim
$60.07
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 hippurate — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection163
Diarrhoea81
Nausea80
Fall74
Fatigue74
Headache65
Dizziness60

Age at onset

Adolescent1
Adult57
Elderly170

Reporter sex

1,210 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization335
Death75
Disabling29
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 129 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Esjay Pharma 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.
← 70685-0001-01 · Esjay 70692-0011-06 · Strive →
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.